Effectiveness of Animal-Assisted Activity on Pain Perception and Anxiety of Children Undergoing Intraoral Local Anesthetic Administration.

Purpose: To investigate the impact of animal-assisted activity (AAA) involving a dog (play therapy) on reducing the pain experienced by children during the administration of local anesthetic (LA). Methods: Children between the ages of eight and 12 years who required LA administration were randomized into an AAA group and a control group. Baseline data for the simplified Modified Child Dental Anxiety Scale-Faces version (MCDAS[f]) was recorded, followed by the implementation of either AAA with standard care or standard care alone. The conventional protocol was followed for the administration of LA. Procedural pain was evaluated using both the Faces Pain Scale-Revised (FPS-R) and the Faces, Legs, Activity, Cry, and Consolability Scale (FLACC). All variations in pulse were also recorded. After the procedure, a simplified MCDAS(f) was recorded once again. The data were tabulated and statistically analyzed. Results: The children in the AAA group reported lower pain scores, as measured by FPS-R, compared to the control group (P =0.009). Pain, as observed in the FLACC scores, was also low in the experimental group (P <0.001). A notable reduction in anxiety scores (P <0.001) was observed among children assigned to the AAA group. Conclusion: AAA involving a dog led to a reduction in the pain experienced by children undergoing LA administration, subsequently decreasing anxiety.

Efficacy of Lidocaine Spray for Pain Reduction during Colposcopy-Directed Cervical Biopsies: A Randomized Controlled Trial.

Objectives: The objective of this study was to evaluate the efficacy of lidocaine spray in reducing the pain during colposcopy-directed cervical biopsy (CDB). Methods: From December 2017 to February 2019, 312 women undergoing CDBs were enrolled. The participants were randomized to three groups: group 1 (lidocaine spray), in which lidocaine spray was applied thoroughly to the cervix; group 2 (placebo), in which normal saline was applied thoroughly to the cervix; and group 3 (control), in which no anesthetic agent was applied to the cervix. Each woman completed a 10 cm visual analog scale to classify the subjective pain experience at three time points: baseline, immediately after biopsy, and 10 min after the procedure. The primary outcome of this study was the biopsy pain score. Results: The 312 enrolled women were randomly assigned to the three groups, amounting to 104 women per group. The clinical and pathological characteristics of the participants in all groups were comparable. The baseline, the biopsy, and the post-procedure pain scores were comparable among the three groups. There was a significant increase in the pain score from baseline to biopsy and from baseline to post-procedure in each group. The pain-score changes from baseline to biopsy in the lidocaine spray group significantly decreased when compared with the normal saline group (<0.001), and tended to decrease, though not significantly (p = 0.06), when compared with the control group. No complication with the intervention was observed. Conclusions: The application of lidocaine spray to the cervix has the benefit of reducing the pain associated with CDBs by a small amount. However, the intervention is safe and may be considered in nulliparous and/or overly anxious women undergoing the procedure.

The effect of virtual reality glasses applied during intrauterine device insertion on pain, anxiety and satisfaction: Randomized controlled study.

BACKGROUND AND AIM: This study was carried out to determine the effect of the use of "virtual reality glasses," on anxiety, pain, and satisfaction level in order to reduce anxiety and pain during intrauterine device (IUD) insertion, which is a painful and stressful procedure for women and to divert attention to increase satisfaction. METHODS: This randomized controlled study in the gynecology clinic of a state hospital with 80 women who were accepted to participate in the study. Data were collected using structured patient information form, numerical pain rating scale, state-trait anxiety inventory, patient satisfaction evaluation form, and virtual reality glasses. RESULTS: Post-procedural pain scores in the control group after IUD application were higher than post-procedural pain in the virtual reality group. Measurements of post-procedure anxiety in the control group were higher than measurements of post-procedural in the virtual reality group. Satisfaction levels of women with virtual reality glasses during IUD insertion were also found to be high. CONCLUSIONS: It was determined that the use of virtual reality glasses, one of the methods of distraction during IUD insertion, was effective in reducing pain and anxiety and increasing patient satisfaction.

Comparing novel virtual reality and nursing standard care on burn wound care pain in adolescents: A randomized controlled trial.

PURPOSE: This study compared the effectiveness of age-appropriate, high technology, interactive virtual reality (VR) distraction with standard care (SC) provided by the nurse on adolescents' acute procedural pain intensity perception during burn wound care treatment in the ambulatory clinic setting. DESIGN: This randomized controlled trial included 43 adolescents ages 10-21 from the ambulatory burn clinic of a large children's hospital. METHODS: Blinded study participants were randomly assigned to either VR or SC (non-significantly different, current mean burn surface area, 1.3 and 1.7, respectively) during the first burn wound care procedure in the burn clinic. Blinded research staff collected pre-procedure data including Spielberger's State-Trait Anxiety Inventory and postprocedure wound care pain intensity using the Adolescent Pediatric Pain Tool. A total of 41 participants completed all study procedures. RESULTS: No statistically significant difference in burn wound care procedural pain was noted between the VR and SC groups after adjusting for several factors. Pre-procedure state and trait anxiety correlated with reported pre-procedure pain. Wound care pain was found to be significantly associated with pre-wound care pain score, time from original burn to clinic burn care treatment, and length of wound care treatment. These factors accounted for approximately 45% of the variation in pain scores during wound care treatment. PRACTICE IMPLICATIONS: VR distraction can be a useful pain management strategy but may not take the place of the unique nurse-patient relationship that occurs during clinical encounters. Tailoring pain management during burn wound care requires consideration of anxiety, time from the burn injury to the wound care procedure, length of time of the wound care procedure, and pretreatment pain level. Knowing patients' needs, desires, and temperaments along with the specifics about the healthcare procedures are critical to formulating individualized care plans that may or may not include VR. Newer technology, such as easier-to-use, less expensive VR, may assist with translation into practice making its clinical use more routine.

Effects of aromatherapy on patient satisfaction with procedural abortion at less than 10 weeks' gestation: A randomized controlled trial.

OBJECTIVES: This study aimed to compare satisfaction with procedural abortion prior to 10 weeks' gestation in patients randomized to lavender essential oil aromatherapy vs placebo (jojoba oil). STUDY DESIGN: This randomized trial compared lavender aromatherapy vs placebo in patients undergoing procedural abortion <10 weeks' gestation. Participants self-administered and inhaled oil during their procedures. Our primary outcome was composite mean score on the Iowa Satisfaction with Anesthesia Scale. Participants completed the State-Trait Anxiety Inventory, a visual analog scale reporting maximum procedural pain, and reported postprocedure aromatherapy acceptability. RESULTS: We analyzed 112 participants randomized to aromatherapy (n = 57) vs placebo (n = 55). Baseline characteristics were similar between groups. We found no difference in overall satisfaction (mean Iowa Satisfaction with Anesthesia Scale scores aromatherapy: 0.72 ± 0.96 vs placebo: 0.46 ± 0.98, p = 0.17) or maximum procedural pain (median visual analog scale score aromatherapy: 65 [range: 4-95] vs placebo: 63 [range: 7-97], p = 0.91). Independent predictors of satisfaction included the use of oral sedation (B: 0.36; 95% CI: 0.04-0.69), state anxiety (B: -0.45; 95% CI: -0.79 to -0.10), and maximum procedural pain (B: -0.17; 95% CI: -0.25 to -0.09). The aromatherapy participants were significantly more likely to have found inhaling scented oil helpful during their procedure (71.9% vs 45.5%; p = 0.005) and would recommend it to a friend who needed a procedural abortion (86.0% vs 56.4%; p = 0.0005) compared to those in the placebo group. Additionally, patients in the aromatherapy group were significantly more likely to agree with the statement, "If I need another procedural abortion, I would want to inhale scented oil during my procedure" (87.7% vs 70.9%; p = 0.03). CONCLUSIONS: The adjunctive use of lavender aromatherapy during first-trimester procedural abortion does not improve satisfaction with anesthesia but is highly valued by patients. IMPLICATIONS: Oral opioids as an adjunct to standard analgesics during procedural abortion (ibuprofen and paracervical block) do not decrease pain, and nonopioid options are lacking. Given current limited anesthesia options, aromatherapy could serve as an affordable and acceptable nonopioid adjunct to current standard of care during procedural abortion. GOV IDENTIFIER: NCT04969900.

Optimizing burn wound procedural pain control, efficiency, and satisfaction through integrated nurse and physician education.

Herein, we report the results of a quality improvement project (QI). Following a review of the burn unit practices, a nursing-led, physician supported educational intervention regarding optimal timing, dosage, and indication for medications used during hydrotherapy, including midazolam and opioids, was implemented. We hypothesized that such intervention would support improvement in both nurse and patient satisfaction with pain control management. Patients undergoing hydrotherapy were surveyed. Demographics, opioid dose prescribed (oral morphine equivalents), midazolam use, timing of administration, and adverse events were collected. Patient pain scores (1-10) before and after hydrotherapy and patient and nurse satisfaction scores (1-10) after hydrotherapy were collected. The pre- and post-education populations were compared. P < 0.05 was considered significant. Post-education, administration of opioids (59.1% v. 0%, p < 0.001) and midazolam (59.1% vs. 10.4%; p < 0.001) prior to hydrotherapy significantly improved, leading to fewer patients requiring rescue opioids during hydrotherapy (25% vs. 74%, p < 0.001). Hydrotherapy duration significantly decreased post-education (19 [13.3-30] min vs. 32 [18-43] min, p = 0.003). Nurses' ratings of their patient's pain control (9 [7.3-10] vs. 7.5 [6-9], p = 0.004) and ease of procedure (10 [9,10] vs. 9 [7.8-10], p = 0.037) significantly improved. Patients' pain management satisfaction rating did not change, but the number of subjects rating their pain management as excellent tended to increase (36.4% vs. 20%, p = 0.077). Nursing led, physician supported, education can improve medication administration prior to and during hydrotherapy, increasing the ease of the procedure as well as staff satisfaction.

Virtual reality and noise canceling headphone distraction during pediatric dermatologic procedures.

Pain and anxiety related to medical procedures have long been recognized as a significant healthcare concern. If a patient's procedural pain and anxiety are not addressed, long-term physical and psychological sequelae including increased perceived pain, anxiety, disruptive behavior, trauma reactions, or refusal of future procedures can occur. The objective of our study was to assess the utility of a virtual reality (VR) headset or noise-canceling headphones (HP) compared to treatment as usual (TAU) in reducing pain and anxiety during pediatric dermatology procedures. Results indicated a significant difference between pre- versus post-procedure anxiety in the VR and HP groups but not the TAU group suggesting non-pharmacologic technology-based interventions such as VR and headphones may reduce patients' anxiety during pediatric dermatology procedures.

Evaluation of procedural pain for neonates in a neonatal intensive care unit: a single-centre study.

BACKGROUND: To evaluate the procedural pain experienced by neonates in a neonatal intensive care unit (NICU) setting and determine the corresponding pain grades. METHODS: Two experienced nurses independently used the Neonatal Infant Pain Scale (NIPS) to evaluate the neonatal pain during procedures taking place in the tertiary NICU and two level-two neonatal care units in the Children's Hospital of Zhejiang University School of Medicine. The mean and distribution of NIPS pain scores and the corresponding pain grades of participants when experiencing clinical painful procedures were analysed. RESULTS: A total of 957 neonates exposed to 15 common clinical painful procedures were included in the study. The clinical painful procedures experienced by 957 participants could be divided into three groups: severe pain (NIPS score 5-7: peripheral intravenous cannulation, arterial catheterisation, arterial blood sampling, peripherally inserted central catheter placement and nasopharyngeal suctioning), mild to moderate pain (NIPS score 3-4: finger prick, intramuscular injection, adhesive removal, endotracheal intubation suctioning, heel prick, lumbar puncture and subcutaneous injection) and no pain to mild pain (NIPS score 0-2: gastric tube insertion, enema and intravenous injection). CONCLUSIONS: The neonatal pain response to clinical procedures in NICU had certain pattern and preintervention drug analgesia could be taken for painful procedures with clustered high NIPS pain scores. Meanwhile, full coverage non-drug pain relief measures could be taken for procedures that are with scattered pain scores, and real-time pain evaluation should be provided to determine whether further drug analgesia is required.

Active production of music as distraction for venipuncture in children and adolescents: a randomized clinical trial.

More than 50% of children report considerable pain during venipuncture or intravenous cannulation. Despite the tools and techniques may be employed to reduce pain and distress in everyday clinical practice, the care offered is frequently insufficient. Music's potential effect in healthcare settings has received increasing attention. This study aimed to verify if the active production of music with a Leap Motion Controller could help decreasing pain and distress during venipuncture in children and adolescents. We conducted an open-label randomized controlled clinical trial with parallel arms. Children aged 8 to 17 were enrolled at the blood-drawing center of the Institute for Maternal and Child Health IRCCS Burlo Garofolo of Trieste, Italy. We hypothesized that in order to demonstrate an adequate improvement in the pain score in the intervention group, at least 200 children, 100 in each group, were needed, with alpha 5% and 1-beta 80%. Differences between the groups were evaluated with the nonparametric Mann-Whitney U-test. The subjects were randomly assigned either to the active production of music group or to the standard of care group. The primary outcome was the median self-reported procedural pain score between experimental and standard of care group. Secondary outcomes were: the median pain and distress scores according to parental judgment and operators' judgment between the experimental and control group. Three hundred subjects entered the study and were randomized, 150 in the active production of music group and 150 in the standard of care group. Median self-reported pain scores were 1 (0-2) in the active production of music group and 2 (1-2) in the standard of care group and this difference was statistically significant (p = 0.0016). Median procedural distress was 1 (0-3) in the active production of music group and 3 (1-6) in the standard of care group, according to parental judgment, and this difference was statistically significant (p = 0.0000016). CONCLUSION: This research showed that the active production of music is a valuable distraction technique to decrease venipuncture related pain and distress in children and adolescents. TRIAL REGISTRATION: The study protocol was registered with ClinicalTrial.gov (June 28[th] 2022, NCT05441241) before the start of the subjects' enrolment. WHAT IS KNOWN: • The benefits of music on pain and anxiety are well known and have been tested during different painful procedures. • The effect of active production of music has never been tested in children during venipuncture. WHAT IS NEW: • In our study median self-reported pain scores and median procedural distress, according to parental judgment, were lower in the active production of music group than in the standard of care group and these differences were statistically significant.

Effect of Acupressure on Pain during Inferior Alveolar Nerve Block Injection in Children Aged 5-10 Years Old - An Experimental Study.

Background: Acupressure, which is related to acupuncture, is a noninvasive therapy suitable for use in children. However, data examining acupressure's effects on the pain of local anesthetic injection in children are sparse. Objectives: The purpose of this study was to evaluate acupressure's effects on the pain of local anesthetic injection in children. Methods: This randomized, double-blind, parallel-group clinical study included 37 5- to 10-year-olds who had an inferior alveolar nerve block (IANB) for a mandibular extraction and were randomized to one of two groups: acupressure (study group) or non-acupressure (control group). The Wong-Baker FACES Pain Rating Scale (WBFPS) and the Sound, Eye, Motor (SEM) scale were utilized for subjective and objective pain assessment during injection. Results: The objective and subjective assessment of pain during injection significantly differed between the groups, with the acupressure group displaying lower scores. Conclusion: Acupressure at the extra one point (EX-HN1) reduced pain during IANB injection in 5- to 10-year-olds and can be used as an adjunct to conventional measures like topical anesthesia to reduce pain.

Breastfeeding or breast milk for procedural pain in neonates.

BACKGROUND: Pain in the neonate is associated with acute behavioural and physiological changes. Cumulative pain is associated with morbidities, including adverse neurodevelopmental outcomes. Studies have shown a reduction in changes in physiological parameters and pain score measurements following pre-emptive analgesic administration in neonates experiencing pain or stress. Non-pharmacological measures (such as holding, swaddling and breastfeeding) and pharmacological measures (such as acetaminophen, sucrose and opioids) have been used for analgesia. This is an update of a review first published in 2006 and updated in 2012. OBJECTIVES: The primary objective was to evaluate the effectiveness of breastfeeding or supplemental breast milk in reducing procedural pain in neonates. The secondary objective was to conduct subgroup analyses based on the type of control intervention, gestational age and the amount of supplemental breast milk given. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and trial registries (ICTRP, ISRCTN and clinicaltrials.gov) in August 2022; searches were limited from 2011 forwards. We checked the reference lists of included studies and relevant systematic reviews. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or quasi-RCTs of breastfeeding or supplemental breast milk versus no treatment/other measures in neonates. We included both term (≥ 37 completed weeks postmenstrual age) and preterm infants (< 37 completed weeks' postmenstrual age) up to a maximum of 44 weeks' postmenstrual age. The study must have reported on either physiological markers of pain or validated pain scores. DATA COLLECTION AND ANALYSIS: We assessed the methodological quality of the trials using the information provided in the studies and by personal communication with the authors. We extracted data on relevant outcomes, estimated the effect size and reported this as a mean difference (MD). We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: Of the 66 included studies, 36 evaluated breastfeeding, 29 evaluated supplemental breast milk and one study compared them against each other. The procedures conducted in the studies were: heel lance (39), venipuncture (11), intramuscular vaccination (nine), eye examination for retinopathy of prematurity (four), suctioning (four) and adhesive tape removal as procedure (one). We noted marked heterogeneity in the control interventions and pain assessment measures amongst the studies. Since many studies included multiple arms with breastfeeding/supplemental breast milk as the main comparator, we were not able to synthesise all interventions together. Individual interventions are compared to breastfeeding/supplemental breast milk and reported. The numbers of studies/participants presented with the findings are not taken from pooled analyses (as is usual in Cochrane Reviews), but are the overall totals in each comparison. Overall, the included studies were at low risk of bias except for masking of intervention and outcome assessment, where nearly one-third of studies were at high risk of bias. Breastfeeding versus control Breastfeeding may reduce the increase in heart rate compared to holding by mother, skin-to-skin contact, bottle feeding mother's milk, moderate concentration of sucrose/glucose (20% to 33%) with skin-to-skin contact (low-certainty evidence, 8 studies, 784 participants). Breastfeeding likely reduces the duration of crying compared to no intervention, lying on table, rocking, heel warming, holding by mother, skin-to-skin contact, bottle feeding mother's milk and moderate concentration of glucose (moderate-certainty evidence, 16 studies, 1866 participants). Breastfeeding may reduce percentage time crying compared to holding by mother, skin-to-skin contact, bottle feeding mother's milk, moderate concentration sucrose and moderate concentration of sucrose with skin-to-skin contact (low-certainty evidence, 4 studies, 359 participants). Breastfeeding likely reduces the Neonatal Infant Pain Scale (NIPS) score compared to no intervention, holding by mother, heel warming, music, EMLA cream, moderate glucose concentration, swaddling, swaddling and holding (moderate-certainty evidence, 12 studies, 1432 participants). Breastfeeding may reduce the Neonatal Facial Coding System (NFCS) score compared to no intervention, holding, pacifier and moderate concentration of glucose (low-certainty evidence, 2 studies, 235 participants). Breastfeeding may reduce the Douleur Aigue Nouveau-né (DAN) score compared to positioning, holding or placebo (low-certainty evidence, 4 studies, 709 participants). In the majority of the other comparisons there was little or no difference between the breastfeeding and control group in any of the outcome measures. Supplemental breast milk versus control Supplemental breast milk may reduce the increase in heart rate compared to water or no intervention (low-certainty evidence, 5 studies, 336 participants). Supplemental breast milk likely reduces the duration of crying compared to positioning, massage or placebo (moderate-certainty evidence, 11 studies, 1283 participants). Supplemental breast milk results in little or no difference in percentage time crying compared to placebo or glycine (low-certainty evidence, 1 study, 70 participants). Supplemental breast milk results in little or no difference in NIPS score compared to no intervention, pacifier, moderate concentration of sucrose, eye drops, gentle touch and verbal comfort, and breast milk odour and verbal comfort (low-certainty evidence, 3 studies, 291 participants). Supplemental breast milk may reduce NFCS score compared to glycine (overall low-certainty evidence, 1 study, 40 participants). DAN scores were lower when compared to massage and water; no different when compared to no intervention, EMLA and moderate concentration of sucrose; and higher when compared to rocking or pacifier (low-certainty evidence, 2 studies, 224 participants). Due to the high number of comparator interventions, other measures of pain were assessed in a very small number of studies in both comparisons, rendering the evidence of low certainty. The majority of studies did not report on adverse events, considering the benign nature of the intervention. Those that reported on adverse events identified none in any participants. Subgroup analyses were not conducted due to the small number of studies. AUTHORS' CONCLUSIONS: Moderate-/low-certainty evidence suggests that breastfeeding or supplemental breast milk may reduce pain in neonates undergoing painful procedures compared to no intervention/positioning/holding or placebo or non-pharmacological interventions. Low-certainty evidence suggests that moderate concentration (20% to 33%) glucose/sucrose may lead to little or no difference in reducing pain compared to breastfeeding. The effectiveness of breast milk for painful procedures should be studied in the preterm population, as there are currently a limited number of studies that have assessed its effectiveness in this population.

Active versus passive distraction for reducing procedural pain and anxiety in children: a meta-analysis and systematic review.

BACKGROUND: Procedural pain is very important in clinical children care. We aimed to evaluate the effects of active versus passive distraction for reducing procedural pain and anxiety in children. METHODS: Two researchers searched the Web of Science, PubMed, EMBASE, Cochrane, SinoMed, Wanfang, China National Knowledge Infrastructure, Weipu databases for the randomized controlled trials(RCTs) on the active versus passive distraction affecting procedural pain and anxiety in children until May 18, 2023. The literature screening and data extraction were carried out by two researchers independently. Review Manager 5.3 software was used for data analysis. RESULTS: 13 RCTs were finally included. 553 children received active distraction intervention and 551 children received passive distraction intervention. There were no significant differences in the children self-reported procedural pain betweent active and passive distraction. The parent-reported procedural pain, medical staff-reported procedural pain, children-reported procedural anxiety, parent-reported procedural anxiety, medical staff-reported procedural anxiety in the active distraction were significant less than that of active distraction. Egger regression analysis showed that there was no publication bias in the results. CONCLUSIONS: Existing evidence suggests that active distraction may be more effective in reducing operational pain and anxiety in children than passive distraction. More studies on the effects of active distraction versus passive distraction in children with larger sample size are needed in the future.

Virtual reality hypnosis for needle-related procedural pain and fear management in children: a non-inferiority randomized trial.

Needle-related procedures can cause pain and fear in children and may lead to avoidance of future medical care. The aim of this study is to investigate whether virtual reality hypnosis (VRH) is non-inferior to medical hypnosis (MH) by a trained healthcare provider in reducing pain in children. This non-inferiority randomized trial was conducted at a teaching hospital in the Netherlands. Children aged 6 to 18 years were randomized to treatment with VRH or MH. The primary outcome was self-reported pain, using the Wong-Baker FACES Scale (WBFS) with the non-inferiority margin defined as a difference of 1.5 points. Secondary outcomes included observer-reported pain (Numeric Rating Scale), fear (scored by children and observers with the Children's Fear Scale), blood pressure, heart rate, treatment satisfaction, and adverse effects. We randomized 138 children to VRH or MH treatment and included 114 children in the analyses (VRH n = 60, MH n = 54). We found non-inferiority for VRH compared to MH on patient-reported pain (mean difference = - 0.17, 95%CI - 1.01;0.66). Secondary outcomes were comparable between VRH and MH groups. Both treatments scored high on patient satisfaction (VRH median = 9.0, MH median = 10.0, p = 0.512). CONCLUSION: VRH may be an effective and safe treatment option besides MH for reducing patient-reported pain in children during a needle-related procedure. VRH was non-inferior to MH in patient-reported fear and both treatments were comparable in terms of patient-reported fear, observer-reported pain and fear, physical distress, and patient satisfaction. TRIAL REGISTRATION: ICTRP https://trialsearch.who.int/ , trial ID NL9385; date registered: 03/04/2021. WHAT IS KNOWN: • Medical hypnosis is effective in reducing procedural distress in children during needle-related procedures. • Virtual reality (VR) is an audiovisual electronic device that guides users into an immersive three-dimensional environment. WHAT IS NEW: • This study shows that VR hypnosis is non-inferior to medical hypnosis in reducing pain and fear in children undergoing a needle-related procedure. • Both VR hypnosis and medical hypnosis were appreciated highly by children to distract them during needle-related procedures.

A Systematic Review of Multisensory Stimulation on Procedural Pain Among Preterm Neonates.

PURPOSE: This systematic review aims to evaluate the quality of studies and synthesize the literature on multisensory stimulation (MSS) on procedural pain among hospitalized preterm neonates. SUMMARY OF KEY POINTS: Search strategies were applied to PubMed/Medline, CINAHL, SCOPUS, and PEDro. A total of 414 studies were identified, 104 were screened, and 4 were included. Two independent reviewers extracted data from identified studies that were synthesized qualitatively and quantitatively. CONCLUSION AND RECOMMENDATIONS FOR CLINICAL PRACTICE: There is strong evidence of MSS in decreasing procedural pain, but additional research is needed to identify the beneficial effects of MSS with a standardized protocol to promote good clinical practice in neonatal intensive care settings. WHAT THIS ADDS TO THE EVIDENCE: High-quality evidence supports beneficial effects of MSS, but standardization of the MSS protocol and its administration needs to be established.

Opioids for procedural pain in neonates.

BACKGROUND: Neonates might be exposed to numerous painful procedures due to diagnostic reasons, therapeutic interventions, or surgical procedures. Options for pain management include opioids, non-pharmacological interventions, and other drugs. Morphine, fentanyl, and remifentanil are the opioids most often used in neonates. However, negative impact of opioids on the structure and function of the developing brain has been reported. OBJECTIVES: To evaluate the benefits and harms of opioids in term or preterm neonates exposed to procedural pain, compared to placebo or no drug, non-pharmacological intervention, other analgesics or sedatives, other opioids, or the same opioid administered by a different route. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was December 2021. SELECTION CRITERIA: We included randomized controlled trials conducted in preterm and term infants of a postmenstrual age (PMA) up to 46 weeks and 0 days exposed to procedural pain where opioids were compared to 1) placebo or no drug; 2) non-pharmacological intervention; 3) other analgesics or sedatives; 4) other opioids; or 5) the same opioid administered by a different route. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were pain assessed with validated methods and any harms. We used a fixed-effect model with risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, and their confidence intervals (CI). We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 13 independent studies (enrolling 823 newborn infants): seven studies compared opioids to no treatment or placebo (the main comparison in this review), two studies to oral sweet solution or non-pharmacological intervention, and five studies (of which two were part of the same study) to other analgesics and sedatives. All studies were performed in a hospital setting. Opioids compared to placebo or no drug Compared to placebo, opioids probably reduce pain score assessed with the Premature Infant Pain Profile (PIPP)/PIPP-Revised (PIPP-R) scale during the procedure (MD -2.58, 95% CI -3.12 to -2.03; 199 participants, 3 studies; moderate-certainty evidence); may reduce Neonatal Infant Pain Scale (NIPS) during the procedure (MD -1.97, 95% CI -2.46 to -1.48; 102 participants, 2 studies; low-certainty evidence); and may result in little to no difference in pain score assessed with the Douleur Aiguë du Nouveau-né (DAN) scale one to two hours after the procedure (MD -0.20, 95% CI -2.21 to 1.81; 42 participants, 1 study; low-certainty evidence). The evidence is very uncertain about the effect of opioids on pain score assessed with the PIPP/PIPP-R scale up to 30 minutes after the procedure (MD 0.14, 95% CI -0.17 to 0.45; 123 participants, 2 studies; very low-certainty evidence) or one to two hours after the procedure (MD -0.83, 95% CI -2.42 to 0.75; 54 participants, 2 studies; very low-certainty evidence). The evidence is very uncertain about the effect of opioids on episodes of bradycardia (RR 3.19, 95% CI 0.14 to 72.69; 172 participants, 3 studies; very low-certainty evidence). Opioids may result in an increase in episodes of apnea compared to placebo (RR 3.15, 95% CI 1.08 to 9.16; 199 participants, 3 studies; low-certainty evidence): with one study reporting a concerning increase in severe apnea (RR 7.44, 95% CI 0.42 to 132.95; 31 participants, 1 study; very low-certainty). The evidence is very uncertain about the effect of opioids on episodes of hypotension (RR not estimable, risk difference 0.00, 95% CI -0.06 to 0.06; 88 participants, 2 studies; very low-certainty evidence). No studies reported parent satisfaction with care provided in the neonatal intensive care unit (NICU). Opioids compared to non-pharmacological intervention The evidence is very uncertain about the effect of opioids on pain score assessed with the Crying Requires oxygen Increased vital signs Expression Sleep (CRIES) scale during the procedure when compared to facilitated tucking (MD -4.62, 95% CI -6.38 to -2.86; 100 participants, 1 study; very low-certainty evidence) or sensorial stimulation (MD 0.32, 95% CI -1.13 to 1.77; 100 participants, 1 study; very low-certainty evidence). The other main outcomes were not reported. Opioids compared to other analgesics or sedatives The evidence is very uncertain about the effect of opioids on pain score assessed with the PIPP/PIPP-R during the procedure (MD -0.29, 95% CI -1.58 to 1.01; 124 participants, 2 studies; very low-certainty evidence); up to 30 minutes after the procedure (MD -1.10, 95% CI -2.82 to 0.62; 12 participants, 1 study; very low-certainty evidence); and one to two hours after the procedure (MD -0.17, 95% CI -2.22 to 1.88; 12 participants, 1 study; very low-certainty evidence). No studies reported any harms. The evidence is very uncertain about the effect of opioids on episodes of apnea during (RR 3.27, 95% CI 0.85 to 12.58; 124 participants, 2 studies; very low-certainty evidence) and after the procedure (RR 2.71, 95% CI 0.11 to 64.96; 124 participants, 2 studies; very low-certainty evidence) and on hypotension (RR 1.34, 95% CI 0.32 to 5.59; 204 participants, 3 studies; very low-certainty evidence). The other main outcomes were not reported. We identified no studies comparing different opioids (e.g. morphine versus fentanyl) or different routes for administration of the same opioid (e.g. morphine enterally versus morphine intravenously). AUTHORS' CONCLUSIONS: Compared to placebo, opioids probably reduce pain score assessed with PIPP/PIPP-R scale during the procedure; may reduce NIPS during the procedure; and may result in little to no difference in DAN one to two hours after the procedure. The evidence is very uncertain about the effect of opioids on pain assessed with other pain scores or at different time points. The evidence is very uncertain about the effect of opioids on episodes of bradycardia, hypotension or severe apnea. Opioids may result in an increase in episodes of apnea. No studies reported parent satisfaction with care provided in the NICU. The evidence is very uncertain about the effect of opioids on any outcome when compared to non-pharmacological interventions or to other analgesics. We identified no studies comparing opioids to other opioids or comparing different routes of administration of the same opioid.

Non-opioid analgesics for procedural pain in neonates.

BACKGROUND: Neonates are an extremely vulnerable patient population, with 6% to 9% admitted to the neonatal intensive care unit (NICU) following birth. Neonates admitted to the NICU will undergo multiple painful procedures per day throughout their stay. There is increasing evidence that frequent and repetitive exposure to painful stimuli is associated with poorer outcomes later in life. To date, a wide variety of pain control mechanisms have been developed and implemented to address procedural pain in neonates. This review focused on non-opioid analgesics, specifically non-steroidal anti-inflammatory drugs (NSAIDs) and N-methyl-D-aspartate (NMDA) receptor antagonists, which alleviate pain through inhibiting cellular pathways to achieve analgesia.  The analgesics considered in this review show potential for pain relief in clinical practice; however, an evidence summation compiling the individual drugs they comprise and outlining the benefits and harms of their administration is lacking. We therefore sought to summarize the evidence on the level of pain experienced by neonates both during and following procedures; relevant drug-related adverse events, namely episodes of apnea, desaturation, bradycardia, and hypotension; and the effects of combinations of drugs.  As the field of neonatal procedural pain management is constantly evolving, this review aimed to ascertain the scope of non-opioid analgesics for neonatal procedural pain to provide an overview of the options available to better inform evidence-based clinical practice.  OBJECTIVES: To determine the effects of non-opioid analgesics in neonates (term or preterm) exposed to procedural pain compared to placebo or no drug, non-pharmacological intervention, other analgesics, or different routes of administration. SEARCH METHODS: We searched the Cochrane Library (CENTRAL), PubMed, Embase, and two trial registries in June 2022. We screened the reference lists of included studies for studies not identified by the database searches. SELECTION CRITERIA: We included all randomized controlled trials (RCTs), quasi-RCTs, and cluster-RCTs in neonates (term or preterm) undergoing painful procedures comparing NSAIDs and NMDA receptor antagonists to placebo or no drug, non-pharmacological intervention, other analgesics, or different routes of administration.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our main outcomes were pain assessed during the procedure and up to 10 minutes after the procedure with a validated scale; episodes of bradycardia; episodes of apnea; and hypotension requiring medical therapy. MAIN RESULTS: We included two RCTs involving a total of 269 neonates conducted in Nigeria and India.  NMDA receptor antagonists versus no treatment, placebo, oral sweet solution, or non-pharmacological intervention One RCT evaluated using oral ketamine (10 mg/kg body weight) versus sugar syrup (66.7% w/w at 1 mL/kg body weight) for neonatal circumcision.  The evidence is very uncertain about the effect of ketamine on pain score during the procedure, assessed with the Neonatal Infant Pain Scale (NIPS), compared with placebo (mean difference (MD) -0.95, 95% confidence interval (CI) -1.32 to -0.58; 1 RCT; 145 participants; very low-certainty evidence). No other outcomes of interest were reported on. Head-to-head comparison of different analgesics One RCT evaluated using intravenous fentanyl versus intravenous ketamine during laser photocoagulation for retinopathy of prematurity. Neonates receiving ketamine followed an initial regimen (0.5 mg/kg bolus 1 minute before procedure) or a revised regimen (additional intermittent bolus doses of 0.5 mg/kg every 10 minutes up to a maximum of 2 mg/kg), while those receiving fentanyl followed either an initial regimen (2 µg/kg over 5 minutes, 15 minutes before the procedure, followed by 1 µg/kg/hour as a continuous infusion) or a revised regimen (titration of 0.5 µg/kg/hour every 15 minutes to a maximum of 3 µg/kg/hour). The evidence is very uncertain about the effect of ketamine compared with fentanyl on pain score assessed with the Premature Infant Pain Profile-Revised (PIPP-R) scores during the procedure (MD 0.98, 95% CI 0.75 to 1.20; 1 RCT; 124 participants; very low-certainty evidence); on episodes of apnea occurring during the procedure (risk ratio (RR) 0.31, 95% CI 0.08 to 1.18; risk difference (RD) -0.09, 95% CI -0.19 to 0.00; 1 study; 124 infants; very low-certainty evidence); and on hypotension requiring medical therapy occurring during the procedure (RR 5.53, 95% CI 0.27 to 112.30; RD 0.03, 95% CI -0.03 to 0.10; 1 study; 124 infants; very low-certainty evidence). The included study did not report pain score assessed up to 10 minutes after the procedure or episodes of bradycardia occurring during the procedure. We did not identify any studies comparing NSAIDs versus no treatment, placebo, oral sweet solution, or non-pharmacological intervention or different routes of administration of the same analgesics. We identified three studies awaiting classification.  AUTHORS' CONCLUSIONS: The two small included studies comparing ketamine versus either placebo or fentanyl, with very low-certainty evidence, rendered us unable to draw meaningful conclusions. The evidence is very uncertain about the effect of ketamine on pain score during the procedure compared with placebo or fentanyl. We found no evidence on NSAIDs or studies comparing different routes of administration. Future research should prioritize large studies evaluating non-opioid analgesics in this population. As the studies included in this review suggest potential positive effects of ketamine administration, studies evaluating ketamine are of interest. Furthermore, as we identified no studies on NSAIDs, which are widely used in older infants, or comparing different routes of administration, such studies should be a priority going forward.

Maternal voice reduces procedural pain in neonates: A meta-analysis of randomized controlled trials.

BACKGROUND: Procedural pain management is a very important part in the clinical care of neonates. We aimed to conduct a meta-analysis to evaluate the effects of maternal voice on neonatal procedural pain, to provide insights to the clinical pain care of neonates. METHODS: Two researchers independently searched PubMed, EMBASE, The Cochrane Library, CINAHL, Web of Science, China Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang and Weipu Database for randomized controlled trials (RCTs) involving the effects of maternal voice on the procedural pain of neonates up to October 25, 2022. Two investigators screened the literature based on the inclusion and exclusion criteria and evaluated the methodological quality of the inclusion study. RevMan 5.3 software was used for the meta-analysis. RESULTS: A total of 8 RCTs with a total of 584 neonates were included. Our meta-analysis indicated that maternal voice reduces the pain score (SMD = -0.60, 95% CI: -0.81 to -0.39) and heart rate (SMD = -0.81, 95% CI: -1.44 to -0.18) and increases the comfort level (SMD = -0.47, 95% CI: -0.83 to -0.11) and blood oxygen saturation (SMD = 0.70, 95% CI: 0.03-1.38) during procedure (all P < .05). Moreover, maternal voice reduces the pain score (SMD = -0.58, 95% CI: -0.88 to -0.28) and heart rate (SMD = -0.44, 95% CI: -0.75 to -0.12) and increases the blood oxygen saturation (SMD = 0.41, 95% CI: 0.00 to -0.82) after procedure (all P < .05). No publication biases were detected by the funnel plots and Egger tests (all P > .05). CONCLUSION: Maternal voice is beneficial to reduce procedural pain and improve the physiological indicators in neonates. It is still necessary to conduct high-quality, large sample studies in the future to further elucidate the effect of maternal voice on neonatal pain care.

Effects of an Immersive Virtual Reality Intervention on Pain and Anxiety Among Pediatric Patients Undergoing Venipuncture: A Randomized Clinical Trial.

Importance: Venipuncture is one of the most painful and distressing procedures experienced by pediatric patients. Emerging evidence suggests that providing procedural information and distraction using immersive virtual reality (IVR) may reduce pain and anxiety among children undergoing needle-related procedures. Objectives: To examine the effects of IVR on reducing the pain, anxiety, and stress experienced by pediatric patients undergoing venipuncture. Design, Setting, and Participants: This 2-group randomized clinical trial recruited pediatric patients aged 4 to 12 years undergoing venipuncture from a public hospital in Hong Kong between January 2019 and January 2020. Data were analyzed from March to May 2022. Interventions: Participants were randomly allocated to an intervention (an age-appropriate IVR intervention offering distraction and procedural information) or a control (standard care only) group. Main Outcomes and Measures: The primary outcome was child-reported pain. Secondary outcomes included child-reported anxiety, heart rate, salivary cortisol, length of procedure, and satisfaction of health care professionals with the procedure (rated on a 40 point scale, with higher scores indicating greater satisfaction). Outcomes were assessed 10 minutes before, during, immediately after, and 30 minutes after the procedure. Results: A total of 149 pediatric patients were recruited, with 86 female patients (57.7%) and 66 patients (44.3%) diagnosed with fever. Compared with the 74 participants in the control group (mean [SD] age, 7.21 [2.49] years), the 75 participants in the IVR group (mean [SD] age, 7.21 [2.43] years) reported significantly less pain (ß = -0.78; 95% CI, -1.21 to -0.35; P < .001) and anxiety (ß = -0.41; 95% CI, -0.76 to -0.05; P = .03) immediately after the intervention. Health care professional satisfaction in the IVR group (mean [SD] score, 34.5 [4.5]) was significantly higher than that in the control group (mean [SD] score, 32.9 [4.0]; P = .03). Moreover, the length of venipuncture procedure in the IVR group (mean [SD] duration, 4.43 [3.47] minutes) was significantly shorter than that in the control group (mean [SD] duration, 6.56 [7.39] minutes; P = .03). Conclusions and Relevance: In this randomized clinical trial, integrating procedural information and distraction in an IVR intervention for pediatric patients undergoing venipuncture significantly improved pain and anxiety in the IVR group compared with the control group. The results shed light on the global trends of research on IVR and its clinical development as an intervention for other painful and stressful medical procedures. Trial Registration: Chinese Clinical Trial Registry identifier: ChiCTR1800018817.

Impact of parent-targeted eHealth educational interventions on infant procedural pain management: a systematic review.

OBJECTIVE: The objective of this review was to determine whether electronic health (eHealth) educational interventions about infant procedural pain and pain management impact parental outcomes (eg, mental health, knowledge uptake), eHealth outcomes (eg, acceptance, use), and pain management outcomes (eg, parental involvement, infant pain response). INTRODUCTION: Pain in infants is a common concern for parents. Routine postpartum care for infants in early life requires them to endure painful procedures, such as immunizations, yet infants often receive little to no pain management. Parents are an essential component of effective pain management, although they may not be aware of the roles they play. Despite the increased number of eHealth resources available to educate parents about infant pain management, their impact has yet to be synthesized. INCLUSION CRITERIA: This review considered studies that evaluated eHealth educational interventions targeted at parents during pregnancy and up to 1 year postpartum. Interventions included, but were not limited to, mobile applications, web-based applications, websites, videos, interactive training, hands-on direct simulation, short message service (SMS), and desktop applications. Primary outcomes included parental outcomes (eg, stress or anxiety, self-efficacy, knowledge, attitudes), eHealth outcomes (eg, acceptance, use), and pain management outcomes (eg, parental involvement, infant pain response). Experimental, quasi-experimental, and observational study designs were included. METHODS: MEDLINE, CINAHL, PsycINFO, Embase, Scopus, Web of Science, and SciELO were searched for studies published in English up to June 14, 2021. Citation lists of relevant reviews and included studies were also searched for additional peer-reviewed articles. Two independent reviewers conducted critical appraisal using standardized tools from JBI, and data extraction, using a data extraction form designed by the authors. Statistical pooling of quantitative data was not possible due to heterogeneity; thus, the findings were reported narratively. RESULTS: A total of 4163 unique studies were screened, with 11 studies ultimately included for synthesis. Five articles were randomized controlled trials, 5 articles were analytical cross-sectional studies, and 1 article was quasi-experimental. Studies reported on 4 unique eHealth educational interventions, all of which used video format and primarily targeted the postnatal period. The findings for all primary outcomes were mixed but suggested either improvements in outcomes or no impact. The certainty of evidence was determined as low or very low across primary outcomes for reasons related to imprecision, risk of bias, and indirectness. CONCLUSIONS: Although heterogeneity of findings limited quantitative synthesis of data, this review suggests that short and engaging educational videos have the potential to positively impact parents' knowledge, confidence, and desire to be involved in procedural pain management for their children. Most of the interventions presented in this review describe evidence-based information about procedural pain management strategies that are known to be effective for infant populations. Thus, it is reasonable to assume that infant pain response should be lower when parents appropriately apply the strategies. However, the findings of this review were not able to confirm this assumption. More research is needed to evaluate the impact of parent-targeted pain management education on infant pain response. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020151569.