Impact of virtual reality on peri-interventional pain, anxiety and distress in a pediatric oncology outpatient clinic: a randomized controlled trial.

PURPOSE: Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic. METHODS: In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. Observational instruments include NRS, FPS-r, BAADS, mYPAS-SF, PedsQL and SSKJ3-8R. All patients undergo two observations: SOC (A) and VR (B) in a randomized order. In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting derived from interprofessional focus group discussion are being explored. RESULTS: Between July 2021 and December 2022 57 eligible patients were included and randomized to the orders A/B (n = 28) and B/A (n = 29). Thirty-eight patients completed both observations. Characteristics in both groups did not differ significantly. More than half of the patients had no previous experience with VR, 5% decided to discontinue VR prematurely. Peri-interventional pain, anxiety and distress were significantly reduced by VR compared with SOC. 71% of patients and 76% of parents perceived punctures with VR to be more relaxed than previous ones. 95% of patients perceived fun with VR goggles. Detailed questionnaires on individual stress and anxiety were returned from 26 of 38 patients. Focus group discussion with staff yielded evidence for successful implementation of VR in an outpatient clinic. CONCLUSIONS: The present study shows that VR can be used for peri-interventional reduction of pain, anxiety, and distress in the special environment of a pediatric outpatient clinic. Specific conditions must be met for successful implementation. Further studies are needed to identify particularly susceptible patients and to illuminate alternatives for distraction that are feasible to implement with limited resources. TRIAL REGISTRATION NUMBER: (ClinicalTrials.gov ID): NCT06235723; 01/02/2024; retrospectively registered. This study adheres to the standard checklist of CONSORT guidelines.

[Virtual reality in the outpatient: reducing anxiety and fear in venous puncture]. / Realidad virtual en el paciente ambulatorio: reduciendo la ansiedad y el miedo en la punción de vías venosas.

Up to 80% of children admitted to a hospital experience pain, mainly associated with venipuncture. OBJECTIVE: To analyze whether the use of virtual reality (VR) headsets during venipuncture can modify the perception of pain, anxiety, and fear in pediatrics. PATIENTS AND METHOD: Open label, randomized clinical trial. The presence of intellectual, visual, or hearing impairment were considered exclusion criteria. Two anxiety and fear scales were administered before and after the procedure, and the Wong-Baker face pain scale at the end. The following were recorded: number of venipuncture attempts, duration of the procedure, and side effects. RESULTS: 78 patients were included, 38 males and a mean age of 9.63 years. In the intervention group, the mean pain value was 2.87, with a mean difference (MD) of -0.85 compared with the control one (95% confidence interval (CI) -2.02 to 0.33). There was a significant reduction in the level of anxiety and fear, with MDs of -2.59 (95%CI: -3.92 to -1.26) and -0.85 points (95%CI: -1.45 to -0.24), respectively. CONCLUSIONS: the use of VR headsets in venipuncture in hospital daytime care decreases the level of anxiety and fear in children and seems to reduce pain, without adverse effects. The venipuncture procedure has the same success rate and does not increase its duration.

The Effect of Swaddling and Oropharyngeal Colostrum During Endotracheal Suctioning on Procedural Pain and Comfort in Premature Neonates: A Randomized Controlled Trial.

BACKGROUND: Endotracheal suctioning (ES) is a painful procedure frequently performed in the neonatal intensive care unit. This procedure negatively affects the comfort level of premature neonates. PURPOSE: To determine the effect of 2 nonpharmacologic methods, swaddling and the administration of oropharyngeal colostrum, on the pain and comfort levels of preterm neonates during ES. METHODS: This randomized controlled experimental study comprised 48 intubated premature neonates (swaddling group n = 16; oropharyngeal colostrum group n = 16; and control group n = 16) at 26 to 37 weeks of gestation. The neonates were swaddled with a white soft cotton cloth or administered 0.4 mL of oropharyngeal colostrum 2 minutes before ES, according to the group in which they were included. Two observers evaluated the pain levels (Premature Infant Pain Profile-Revize [PIPP-R]) and comfort (Newborn Comfort Behavior Scale [COMFORTneo]) of the infants by observing video recordings of before, during, and after the procedure. FINDINGS/RESULTS: A significantly lower mean PIPP-R score was found in the swaddling group during ES compared with the control group ( P = .002). The mean COMFORTneo scores of the swaddling and oropharyngeal colostrum groups during ES ( P < .01, P = .002) and the mean PIPP-R and COMFORTneo scores immediately after ES and 5, 10, and 15 minutes later were significantly lower than the control group ( P < .005). IMPLICATIONS FOR PRACTICE AND RESEARCH: Swaddling was effective both during and after the procedure, while oropharyngeal colostrum was effective only after the procedure in reducing ES-related pain in premature neonates. Swaddling and oropharyngeal colostrum were effective in increasing comfort both during and after the procedure.

EMLA cream in burns: A systematic review of safety, analgesic efficacy, and effects on burn pathophysiology.

AIM: Management of procedural pain in burn care is challenging. Lidocaine-prilocaine cream 5%, eutectic mixture of local anesthetics (EMLA®), is a widely used, effective local anesthetic cream approved for normal intact skin, genital mucosa for superficial surgical procedures, and debridement of chronic leg ulcers. This comprehensive review aimed to determine the safety, analgesic efficacy, and effects of EMLA on burn pathophysiology to provide evidence-based clinical recommendations for introducing the topical anesthetic into burn care. METHODS: The PRISMA guidelines were followed for conducting a systematic PubMed search to include all relevant preclinical and clinical studies, according to pre-specified eligibility criteria. RESULTS: Fifteen studies were included in a qualitative synthesis, among which nine were human and six were animal studies. To date, safety and pharmacokinetic data on EMLA application in burns have been limited. Nevertheless, human studies indicated that EMLA is safe and provides adequate procedural-pain relief in adults when applied to smaller burns. Caution should be exercised when using EMLA in younger children, as systemic toxicity, pertaining to prilocaine-induced methemoglobinemia, has been reported owing to overdosing (high doses applied over large burn areas). Furthermore, animal studies demonstrate the potential beneficial effects of EMLA on burn pathophysiology such as anti-inflammatory, decreased capillary permeability to plasma proteins and edema formation, and improved tissue perfusion, which are factors that may impact burn wound progression. CONCLUSION: Current data on EMLA use in the management of procedural pain in small burns are sparse but suggest that EMLA is safe and effective in adults. Further clinical pharmacokinetic studies are warranted, especially for application on larger burn areas.

Unsedated colonoscopy utilizing virtual reality distraction: a pilot-controlled study.

BACKGROUND: Sedation increases colonoscopy risks and prolongs recovery time. We examined whether virtual reality (VR) can substitute for sedation. The primary outcome was the overall satisfaction of patients who underwent colonoscopy with VR headset compared with patients who underwent standard sedation. Pain during the procedure, polyp detection rate (PDR), colonoscopy duration, post-colonoscopy adverse events, post-colonoscopy recovery, time-to-return to daily functions, and turnaround time at the endoscopy unit were secondary outcomes. METHODS: The study was approved by Sheba Medical Center's ethics committee IRB number 21-8177-SMC. Sixty patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure, and all patients signed a written informed consent. 28/30 patients successfully completed the colonoscopy using VR headset. Overall satisfaction score was comparable between the groups. RESULTS: There was no difference between VR and controls in colonoscopy duration, or PDR. VR patients had numerically lower rate of post-colonoscopy adverse events than controls. The proportion of VR patients who reported resuming daily activities on the day of the procedure was significantly higher than in the control group. The VR group patients spent significantly less time in the hospital compared to the control group. CONCLUSIONS: VR technology can provide adequate substitution for sedation for most patients undergoing colonoscopy and offers comparable patient satisfaction and faster return to daily activities.

Efficacy of intrauterine device procedural analgesics.

ABSTRACT: Nearly half of all pregnancies worldwide are unintended. Intrauterine devices are an effective, long-acting form of pregnancy prevention that require minimal maintenance, and also can be used in patients with menorrhagia. However, they are underused because of pain associated with their insertion. Topical and local anesthesia are good options for reducing procedural pain in select patients. IUD placement falls within the scope of practice for physician associates/assistants (PAs) practicing in family medicine, internal medicine, and women's health. PAs should be aware of these additional analgesia options available to patients in order to increase use of effective contraception.

Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study.

INTRODUCTION: Oral sucrose is repeatedly administered to neonates in the neonatal intensive care unit (NICU) to treat pain from commonly performed procedures; however, there is limited evidence on its long-term cumulative effect on neurodevelopment. We examined the association between total sucrose volumes administered to preterm neonates for pain mitigation in the NICU and their neurodevelopment at 18 months of corrected age (CA). METHODS: A prospective longitudinal single-arm observational study that enrolled hospitalised preterm neonates <32 weeks of gestational age at birth and <10 days of life was conducted in four level III NICUs in Canada. Neonates received 0.1 mL of 24% sucrose 2 min prior to all commonly performed painful procedures during their NICU stay. Neurodevelopment was assessed at 18 months of CA using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Multiple neonatal and maternal factors known to affect development were adjusted for in the generalised linear model analysis. RESULTS: 172 preterm neonates were enrolled and 118 were included in the analysis at 18 months of CA. The total mean sucrose volume administered/neonate/NICU stay was 5.96 (±5.6) mL, and the mean Bayley-III composite scores were: cognitive 91 (±17), language 86 (±18) and motor 88 (±18). There was no association between Bayley-III scores and the total sucrose volume: cognitive (p=0.57), language (p=0.42) and motor (p=0.70). CONCLUSION: Cumulative sucrose exposure for repeated procedural pain in preterm neonates was neither associated with a delay in neurodevelopment nor neuroprotective effects at 18 months of CA. If sucrose is used, we suggest the minimally effective dose combined with other non-pharmacological interventions with demonstrated effectiveness such as skin-to-skin contact, non-nutritive sucking, facilitated tucking and swaddling. TRIAL REGISTRATION NUMBER: NCT02725814.

Strategies to minimize procedure-related pain and anxiety: lessons from pediatric dermatology.

PURPOSE OF REVIEW: Recent studies have suggested that prolonged or repeated episodes of general anesthesia early in childhood may adversely affect neurodevelopment. This, combined with rising healthcare costs and decreasing access, has sparked interest in performing pediatric procedures in the office setting when possible. It is essential to address the physical and psychological discomfort that often accompany this experience, particularly in children. RECENT FINDINGS: Healthcare providers performing procedures on children can draw from a spectrum of established techniques, new technology, and novel use of medications to decrease peri-procedural pain and anxiety. These techniques include distraction, optimization of local anesthesia, and mild to moderate sedation. SUMMARY: We recommend using a combination of techniques to minimize pain and anxiety to improve safety, decrease healthcare costs, improve patient experience, and prevent childhood trauma and persistent negative perception of the healthcare system.

Optimizing pediatric periprocedural pain management part II-Adjunct therapies to support the use of infiltrative anesthetics.

Pediatric procedure-related pain management is often incompletely understood, inadequately addressed, and critical in influencing a child's lifelong relationship with the larger healthcare community. We present a comprehensive review of infiltrative anesthetics, including a comparison of their mechanisms of action and relative safety and efficacy data to help guide clinical selection. We also describe the multimodal utilization of adjunct therapies-in series and in parallel-to support the optimization of pediatric periprocedural pain management, enhance the patient experience, and provide alternatives to sedation medication and general anesthesia.

Risk Factors and Contemporary Management Options for Pain and Discomfort Experienced During a Prostate Biopsy.

PURPOSE OF REVIEW: Prostate fusion biopsy, an innovative imaging modality for diagnosing prostate cancer, presents certain challenges for patients including discomfort and emotional distress, leading to nonadherence to treatment and follow-ups. To inform clinicians and offer pain relief alternatives to patients, this review delves into the risk factors for increased pain and modern management options to alleviate pain during prostate biopsy. RECENT FINDINGS: Individual responses to pain vary, and the overall experience of pain during a prostate biopsy has been contributed to numerous factors such as patient age, prostate volume, previous biopsy experience, and more. As a result, several strategies aim to mitigate pain during in-office procedures. Notably, techniques including pharmacological analgesics, hand holding, heating pads, entertainment/virtual reality, and distraction have shown significant efficacy. Existing studies explore risk factors influencing pain intensity during prostate biopsy and effective pain management strategies. This review consolidates available information to guide clinicians in enhancing patient comfort and thus, encourage surveillance adherence.

Investigating visual preferences of clinical mechanical anesthetic vibration: a cross-sectional image survey.

While mechanical vibration lessens discomfort associated with injection site pain (ISP), many local anesthetic injectors (LAIs) do not use vibratory anesthetic devices (VADs). Injector preference of vibration device is influenced by functional concerns, but qualitatively there is an element of adoption that is driven by visual feedback. We sought to capture operator preferences of vibration device design elements to further understand why injectors do not use these devices. We conducted a survey of image preferences among nurses and medical assistants employed at 8 dermatological clinics to investigate barriers to VAD use. Images were electronically modified with features distinct from the original device (a VAD commonly used in clinical practice). Participants rated their likelihood and comfort of use of each VAD represented in the images. Two-sample t-tests were used to compare the rating of the unmodified VAD to each modified VAD within participants. A response rate of 100% was achieved with 35 participants (average age, 38.5 years; 6 (17.1%) male, 29 (82.9%) female). Despite 28 (80%) participants knowing that mechanical vibration reduces ISP, only 16 (45.7%) endorsed ever using mechanical vibration as topical anesthetic. Images modified by pattern, color, and sterility covering were rated significantly lower than the original, unmodified VAD image (plain white VAD), confirming that visual feedback does impact adoption. Through independent comment categorization, aesthetics were found to be important to LAIs. Aesthetic preferences opposing functional concerns may factor into the lack of VAD use. Defining these visual preference barriers to adoption may help promote VAD use during dermatologic procedures.

Effectiveness and safety of Buzzy device in needle-related procedures for children under twelve years of age: A systematic review and meta-analysis.

BACKGROUND: Pain transcends simple physiology, encompassing biological, emotional, psychological, and social facets. Children show pronounced immediate and enduring responses to pain-related procedures. The aim of this meta-analysis is to investigate the efficacy and safety of the Buzzy device for needle-related procedures in children aged twelve years or younger. METHODS: PubMed, Web of Science, and Embase were searched from inception to July 2023. Only randomized controlled trials utilizing the Buzzy device for needle-related procedures in children under twelve years old were included. Two reviewers independently conducted study selection, data extraction, and risk of bias assessment. Random-effects models were utilized, and analyses were performed using mean differences or standardized mean differences as well as risk ratios. RESULTS: A total of 19 studies were included, involving 2846 participants (Buzzy = 1095, Control = 1751). Compared to no intervention, the Buzzy device significantly reduced pain response [self-report SMD = -1.90 (-2.45, -1.36), parental SMD = -3.04 (-4.09, -1.99), observer SMD = -2.88 (-3.75, -2.02)] and anxiety scores [self-report SMD = -1.97 (-3.05, -0.88), parental SMD = -2.01 (-2.93, -1.08), observer SMD = -1.92 (-2.64, -1.19)]. Compared to virtual reality (VR), the Buzzy device reduced self-reported anxiety levels SMD = -0.47 (-0.77, -0.17), and compared to distraction cards, the Buzzy device reduced parental and observer-reported pain [parental SMD = -0.85 (-1.22, -0.48), observer SMD = -0.70 (-1.00, -0.40)] and anxiety [parental SMD = -0.96 (-1.46, -0.47), observer SMD = -0.91 (-1.40, -0.42)]. Subgroup analysis results showed that procedure type, patient age, measurement scales used, and distance of operation were not the reason of heterogeneity. The summarized first puncture attempt success rate did not differ from other interventions. There were no significant adverse events in the included studies. CONCLUSION: The Buzzy device reduces pain and anxiety in children during needle procedures, ensuring success and safety. Additionally, the effectiveness of the Buzzy device in reducing pain during venipuncture is superior when compared to its effectiveness during intramuscular injections.

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.

Virtual Reality for the Management of Pain and Anxiety for IR Procedures: A Prospective, Randomized, Pilot Study on Digital Sedation.

PURPOSE: To assess the analgesic and anxiolytic effects of virtual reality (VR) augmentation in patients undergoing peripherally inserted central catheter (PICC) placement or fine-needle aspiration thyroid biopsy. MATERIALS AND METHODS: This is a prospective, single-center randomized controlled trial with 107 patients enrolled. Patients were randomly assigned to receive standard of care (SOC) or SOC+VR during PICC or thyroid biopsy procedures. Pain and anxiety were individually measured using the visual analog scale (VAS) before and after the procedure. Vital signs including heart rate and systolic and diastolic blood pressure were recorded. One-way analysis of variance test and Games-Howell post hoc analysis were used to assess effect size and statistical significance between SOC and SOC+VR measures. RESULTS: The PICC cohort consisted of 59 patients (33 in SOC+VR and 26 in SOC), with a median age of 53.1 years (interquartile range [IQR], 38.3-62.7 years). The thyroid biopsy cohort consisted of 48 patients (26 in SOC+VR and 22 in SOC), with a median age of 60.1 years (IQR, 49.0-67.2 years). One-way analysis of individuals undergoing thyroid biopsies with adjunctive VR revealed an effect size of -1.74 points (SE ± 0.71; P = .018) on VAS pain scale when compared with SOC. Analysis of individuals undergoing PICC placements revealed an effect size of -1.60 points (SE ± 0.81; P = .053) on VAS anxiety when compared with SOC. CONCLUSIONS: VR as a nonpharmacologic adjunct reduced some procedure-related pain and anxiety without increasing the procedural duration.

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.

Management of Procedural Pain and Anxiety in Youth With Autism Spectrum Disorder: A Scoping Review.

BACKGROUND: Although there is a body of literature on the implementation of interventions to manage procedural pain and anxiety in youth with autism spectrum disorders (ASD), we found no literature presenting the current state of knowledge on this topic. OBJECTIVES: To review the state of knowledge on interventions for the management of procedural pain and anxiety in children and adolescents with ASD. METHOD: A scoping review using PRISMA-ScR was conducted. DATA SOURCES: PubMed, MEDLINE, all EBM reviews, Embase, APA PsychInfo, EBSCO CINAHL, and ProQuest Dissertations and Theses Global databases were searched. Gray literature was also searched. ANALYSIS METHOD: Braun and Clarke's (2006) model for thematic analysis in psychology was used to synthesize the search results. RESULTS: Thirty articles were selected. Analysis of the extracted data revealed four elements of intervention for better management of procedural pain and anxiety in the study population: 1) characteristics of the procedure and the immediate environment; 2) parent-child interactions; 3) health care provider-child interactions; and 4) direct pharmacological and nonpharmacological interventions. IMPLICATIONS FOR NURSING PRACTICE: Nurses must be able to implement appropriate interventions for the management of procedural pain and anxiety in youth with an autism spectrum disorder.

Evaluation of thermal shock therapy for reducing pain during intense pulsed light therapy: An intrapatient randomized controlled study.

BACKGROUND: Intense pulsed light (IPL) is used for the treatment and improvement of various skin issues. However, patients often experience local skin burning and pain after IPL treatment. Cooling and analgesic measures are indispensable. AIMS: To investigate the clinical effect of thermal shock therapy on pain relief and reduction of adverse reactions during IPL therapy. PATIENTS/METHODS: A total of 60 female patients with facial photoaging who received IPL therapy were enrolled in the study. As a comparative split-face study, one side of the face was randomly selected as the control side. The other side was given thermal shock therapy before and after the IPL treatment immediately as analgesic side. The visual analog scale (VAS) was used to evaluate the pain degree of the patients. The telephone follow-ups regarding the occurrence of adverse reactions were conducted respectively on the 2nd day, 7th day, and 1 month after treatment. RESULTS: The VAS score and skin temperature of analgesia side was lower than that of control side at different stages of treatment. In terms of adverse reactions, the incidence of transient facial redness on the analgesic side was lower than that on the control side. Two patients showed slight secondary pigmentation on the control side, and the other patients showed no other adverse reactions on both sides. CONCLUSIONS: Thermal shock therapy assisted IPL therapy can reduce skin temperature during treatment, effectively relieve patients' pain, reduce the occurrence of adverse reactions caused by heat injury, and improve patients' comfort level.

Effect of photobiomodulation therapy on pain perception during anesthetic puncture of dental local anesthesia: A systematic review.

BACKGROUND: Local anesthetic puncture is often related to the experience of pain. This study aimed to systematically analyze the literature on changes in pain perception during the anesthetic puncture of dental local anesthesia after Photobiomodulation Therapy (PBMT). MATERIAL AND METHODS: An electronic search was performed in eight primary databases (Embase, LILACS, BBO, LIVIVO, MedLine via PubMed, SciELO, Scopus, and Web of Science) and three additional ones (EASY, Google Scholar, and OATD) to partially capture the "gray literature". The PICO strategy was used to identify randomized clinical trials evaluating the analgesic effect of PBMT in the anesthetic puncture site of dental local anesthesia compared to placebo or control groups, without restrictions on publication language and year. Two reviewers extracted the data and assessed the individual risk of bias of the eligible studies using the Cochrane Collaboration Risk of Bias Tool version 2.0. RESULTS: The electronic search found 3,485 records, of which eight met the eligibility criteria and were included in the qualitative synthesis. The studies were published from 2011 to 2022. None of the included studies had a low risk of bias. PBMT groups showed no significant difference in pain scores compared to placebo and control groups of most studies. CONCLUSION: Based on a low to very low certainty of evidence, PBMT seems to have no effect on pain perception during anesthetic puncture in patients undergoing dental local anesthesia.

Analgesia efficacy of lidocaine transfused by a novel disposable injectable cervical dilator during intrauterine device removal procedure: A randomized clinical trial.

OBJECTIVE: The majority of intrauterine devices (IUDs) inserted in China are tailless, requiring intrauterine manipulations for removal and causing pain. This study aimed to investigate the analgesic efficacy of lidocaine injection into a novel disposable injectable cervical dilator for IUD removal procedures. STUDY DESIGN: A double-blinded, placebo-controlled, randomized clinical trial was conducted with women aged 18-65 years old requesting outpatient IUD removal. The study randomly assigned participants to either lidocaine (injecting 5 ml of 2% lidocaine into the injectable cervical dilator) or placebo (injecting 5 ml of normal saline into the device) group. All participants received a standardized paracervical block. The primary outcome was pain reported during IUD removal on a 100 mm Visual Analog Scale (VAS). Intention-to-treat were conducted to evaluate the analgesic effectiveness of injecting lidocaine into the injectable cervical dilators. RESULTS: We enrolled seventy-four eligible participants (37 in lidocaine group and 37 in placebo group). The results showed that the median intraoperative VAS score in the lidocaine group was lower than the placebo group (30.0 mm [IQR 20.0-46.0, n = 37] vs 46.0 mm [IQR 30.0-55.0, n = 37], p = 0.01. In subgroup analyses, among participants with IUD removal and without uterine manipulation and additional procedures, there was no statistically significant disparity observed in intraoperative VAS scores between the lidocaine and placebo group (15.0 mm [IQR 10.0-27.5, n = 8] vs 20.0 mm [IQR 20.0-40.0, n = 6]), p = 0.28). Among participants with an IUD removal necessitating intrauterine manipulations and without additional procedures, showing lower intraoperative VAS scores in lidocaine group (25.0 mm [IQR 15.0-40.5, n = 17]) compared to placebo group (46.0 mm [IQR 38.5-50.0, n = 23]), p < 0.01. Among participants with additional procedures in addition to IUD removal, there was no statistically significant disparity observed in intraoperative VAS scores between the lidocaine and placebo group (41.0 mm [IQR 32.5-57.5, n = 12] vs 45.0 mm [IQR 22.5-69.0, n = 8]), p = 0.97). CONCLUSIONS: Injecting lidocaine into the novel disposable injectable cervical dilator for cervix dilation can significantly reduce pain during an IUD removal, particularly in patients necessitating intrauterine manipulations during IUD removal. IMPLICATIONS: When we have to perform intrauterine manipulations to remove an IUD, surgical pain and narrow cervical canal undoubtedly affect the implementation of the procedure. Injecting lidocaine into the injectable cervical dilator can achieve local anesthesia while dilating the cervix, and might reduce the choice of general anesthesia for IUD removal.