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.

Non-pharmacological interventions to reduce procedural needle pain in children (6-12 years): A systematic review.

PROBLEM: Children of different age groups frequently undergo painful procedures involving needles, which can be a source of significant discomfort. Regrettably, this aspect of care often receives insufficient attention from healthcare professionals. The existing literature proposes several methodologies for managing procedural pain, with nonpharmacological techniques being particularly promising. These techniques should be adapted to the patient's age, but literature predominantly emphasizes their use with infants. Thus, it is necessary to evaluate their effectiveness in diverse age groups. Consequently, the purpose of this systematic review is to identify non-pharmacological interventions used to prevent needle-related procedural pain in children (age group 6-12 years). ELIGIBILITY CRITERIA: Primary studies in English language on non-pharmacological interventions in children aged 6-12 years undergoing needle-related procedures found on PubMed, CINAHL and Embase. SAMPLE: A total of 18 studies were included. RESULTS: The results indicate the potential application of various non-pharmacological techniques, with distraction methods standing out. These techniques include activities like utilizing cards, watching cartoons, employing virtual reality and playing video games. CONCLUSIONS: Children's procedural pain represents a significant challenge in treatment plans. Literature offers several approaches, including nonpharmacologic methods, to control this problem. Prioritizing procedural pain management is critical both at clinical and organizational levels to improve the quality of pediatric care. IMPLICATIONS: These findings offer different options to support clinical practice, holding the potential to enhance the quality of patient care.

Effectiveness of ShotBlocker application on reducing the pain of needle-related procedures in children: A systematic review and meta-analysis.

PROBLEM: Needle-related procedures are quite common throughout life, especially during childhood. Pain caused by these procedures is the most common complication. ShotBlocker is an alternative non-pharmacological method to reduce pain during injection-related procedures. However, the effectiveness of the ShotBlocker application in children for reducing pain needle-related procedures remains unclear. This review aimed to evaluate the effectiveness of ShotBlocker application on pain during needle-related procedures in children from Randomized Controlled Trials. ELIGIBILITY CRITERIA: Eight electronic databases were searched until November 2023 for articles published in English. The methodological quality and evidence strength were appraised using the Cochrane Risk of Bias 2 tool and the GRADE approach. A random-effects model was used to determine the effect of the ShotBlocker application on pain levels. The review included results involving assessments from the child, parents, and an observer in pain evaluation. SAMPLE: A total of nine studies with 1205 children patients were included. RESULTS: The evaluation data showed that ShotBlocker application significantly reduced the pain caused by needle-related procedures in children. The Cochrane GRADE approach showed moderate level evidence for the effect of ShotBlocker application on pain during needle procedures. CONCLUSIONS: As a result of the studies included in this meta-analysis, it was determined that ShotBlocker application significantly reduced the pain caused by needle-related procedures in children. IMPLICATIONS: ShotBlocker, a non-pharmacological method, can be used by pediatric nurses to reduce pain during needle-related procedures in children. Randomized controlled studies with well-designed methods are needed to create strong evidence in this field.

A Cross-Sectional Survey on Pain Management in Dermal Filler Injections from Physicians' and Patients' Perspectives.

BACKGROUND: Hyaluronic acid (HA) dermal fillers injection is a common procedure in patients with cosmetic needs. Concomitant pain is a major complaint among patients undergoing HA filler injections. Relevant research is limited and there is no consensus on pain management of dermal filler injection. OBJECTIVES: To assist physicians in determining a more appropriate treatment approach, and to better provide treatment suggestions. METHODS: A nationwide (China) cross-sectional survey was conducted using questionnaires designed for physicians and patients, respectively. A total of 62 semi-structured questionnaires were administered to aesthetic physicians via face-to-face interview, whereas 123 online-based questionnaires were collected from patients who have ever undergone HA treatment. The collected questionnaire information was analyzed using descriptive statistics and content analysis. RESULTS: 42 (67.74%) physicians observed that over 50% of their patients were concerned about pain during injection. 101 (82.11%) of patients were concerned about impending pain ≥5 points (a total score is 10) before injection. For preferred pain relief modalities, 48 (77.42%) physicians would choose a hyaluronic acid dermal filler with lidocaine, and 82 (66.67%) patients would choose anesthetic-containing products. 59 (95.16%) physicians who injected lidocaine-containing hyaluronic acid found patients had a comfortable treatment experience. CONCLUSIONS: Pain management during hyaluronic acid dermal fillers injection is important from both perspectives of physicians and patients. This survey showed that compared with other analgesic methods, lidocaine-containing hyaluronic acid has offered a more satisfying experience. It also provides insights to physicians and patients in pain management. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Efficacy and Pain Tolerance of Alexandrite Laser Hair Removal at Different Stages of the Menstrual Cycle.

BACKGROUND: Several different parameters play a role in the transition of hair follicles to the anagen phase, with the role of androgens, progesterone, and estrogen hormones and receptors being significant. OBJECTIVES: The effectiveness of laser hair removal (LHR) and pain tolerance during procedure were investigated during 3 different phases of the menstrual cycle. METHODS: Forty-eight axillae were randomly divided into 3 groups: menstruation, ovulation, and luteal. Three laser sessions were performed on each axilla at a 1-month interval. Blood hormone levels were measured in the patients. An alexandrite laser was applied during LHR sessions. Before each LHR session and 1 month after the third session, hair follicles in 4-cm2 areas in the center of the axillae were counted. Patients self-assessed the pain they felt during the laser application in each session with a visual pain scale. RESULTS: The average values for hair counting in the groups were as follows (M, menstruation; O, ovulation; L, luteinization): M0 = 47.6, M1 = 27.4, M2 = 16.1, M3 = 9.9; O0 = 41.8, O1 = 21.1, O2 = 13.8, O3 = 8.6; and L0 = 49.4, L1 = 27.1, L2 = 15.1, L3 = 9.8. The average values on the visual analog scale scores in the groups were: M1 = 3.94, M2 = 3.06, M3 = 1.94; O1 = 3.50, O2 = 3.06, O3 = 1.69; and L1 = 3.63, L2 = 2.50, L3 = 1.56. Statistical analysis was conducted with Tukey post hoc analysis after analysis of variance. CONCLUSIONS: The results of LHR are not affected by changes in hormone levels during the menstrual cycle in females. Although not statistically significant, it has been observed that pain tolerance during laser application is lower during the menstruation cycle.

ALPS-Neo pain and stress assessment scale for neonates-A measure for procedural pain.

AIM: The aim of this study was to investigate psychometric properties, reliability and validity, of Astrid Lindgren and Lund Children's Hospitals Pain and Stress Assessment Scale for Preterm and Sick Newborn Infants (ALPS-Neo), as a measure for procedural pain. METHODS: This observational, prospective study with a repeated measures design, explored inter-rater reliability by two raters assessing 21 neonates during non-pain and pain events. Construct validity was explored, that is, ability to discriminate between non-pain and pain, and criterion validity by correlating ALPS-Neo with Premature Infant Pain Profile-Revised (PIPP-R) and Skin Conductance Algesimeter (SCA) in 54 neonates without ventilator support and sedation undergoing routine heel-stick procedure in a tertiary neonatal intensive care unit. RESULTS: Mean gestational and assessment age of 54 infants was 33.8 weeks and 12.7 days respectively. Inter-rater reliability from baseline, skin wiping, heel-stick events for 21 infants demonstrated intraclass correlations with 95% confidence intervals (CI) of 0.49 (-0.27 to 0.79), 0.86 (0.65-0.94) and 0.73 (0.34-0.89) respectively. ALPS-Neo discriminated significantly between baseline, non-pain and heel-stick (mean differences from pain event -2.3 and -1.0 respectively) and correlated during heel-stick with PIPP-R (r = 0.56, 95% CI: 0.34-0.72), not with SCA. CONCLUSION: ALPS-Neo may be used as a measure for procedural pain.

Assessment of salivary cortisol concentrations for procedural pain monitoring in newborns.

OBJECTIVES: The study aimed to evaluate the usefulness of salivary cortisol (SC) for the assessment of procedural pain intensity in preterm and term newborns. METHODS: Three groups of neonates (term, 370-416 weeks; moderate to late preterm, 320-366; and very preterm, <320) hospitalized in neonatal intensive care unit were assessed for the study. Response to nappy change, lung ultrasound (LUS), and blood sampling was analyzed. The intensity of pain was evaluated using continuous heart rate and blood oxygen saturation (SpO2) monitoring, Neonatal Infant Pain Scale (NIPS), and SC concentrations. Saliva samples were collected before and 20 min after the procedure's end. RESULTS: Seventy-one infants were examined: 30 term, 21 moderate to late preterm, and 20 very preterm. SC has increased significantly in response to nappy change only in very preterm newborns (2.13 ng/mL [1.55-3.68] vs. 2.84 ng/mL [1.93-9.06], p = 0.01). LUS did not affect concentrations of SC in any group. Significant increase in SC was observed after blood sampling in term and very preterm infants (2.2 ng/mL [1.45-2.92] vs. 4.29 ng/mL [3.88-5.73], p = 0.002, and 1.88 ng/mL [1.47-4.13] vs. 5.3 ng/mL [3.42-8.02], p = 0.002, respectively). A significant correlation between values of SC increase and NIPS scores was found (Spearman's rank correlation coefficient [rs] = 0.31, p = 0.001). CONCLUSIONS: We observed the increase in SC concentrations in response to painful stimulus. The presence of a correlation between NIPS scores and SC increase suggests that SC can be used as an objective parameter to assess pain in neonates.

The Clinical Suitability of an Artificial Intelligence-Enabled Pain Assessment Tool for Use in Infants: Feasibility and Usability Evaluation Study.

BACKGROUND: Infants are unable to self-report their pain, which, therefore, often goes underrecognized and undertreated. Adequate assessment of pain, including procedural pain, which has short- and long-term consequences, is critical for its management. The introduction of mobile health-based (mHealth) pain assessment tools could address current challenges and is an area requiring further research. OBJECTIVE: The purpose of this study is to evaluate the accuracy and feasibility aspects of PainChek Infant and, therefore, assess its applicability in the intended setting. METHODS: By observing infants just before, during, and after immunization, we evaluated the accuracy and precision at different cutoff scores of PainChek Infant, which is a point-of-care mHealth-based solution that uses artificial intelligence to detect pain and intensity based solely on facial expression. We used receiver operator characteristic analysis to assess interpretability and establish a cutoff score. Clinician comprehensibility was evaluated using a standardized questionnaire. Other feasibility aspects were evaluated based on comparison with currently available observational pain assessment tools for use in infants with procedural pain. RESULTS: Both PainChek Infant Standard and Adaptive modes demonstrated high accuracy (area under the curve 0.964 and 0.966, respectively). At a cutoff score of ≥2, accuracy and precision were 0.908 and 0.912 for Standard and 0.912 and 0.897 for Adaptive modes, respectively. Currently available data allowed evaluation of 16 of the 17 feasibility aspects, with only the cost of the outcome measurement instrument unable to be evaluated since it is yet to be determined. PainChek Infant performed well across feasibility aspects, including interpretability (cutoff score defined), ease of administration, completion time (3 seconds), and clinician comprehensibility. CONCLUSIONS: This work provides information on the feasibility of using PainChek Infant in clinical practice for procedural pain assessment and monitoring, and demonstrates the accuracy and precision of the tool at the defined cutoff score.

Quantifying procedural pain associated with office gynecologic tract sampling methods.

OBJECTIVE: Emerging technologies may enable detection of endometrial cancer with methods that are less invasive than standard biopsy methods. This study compares patient pain scores among 3 office gynecologic tract sampling methods and explores their potential determinants. METHODS: A prospective study including 3 sampling methods (tampon, Tao brush (TB), endometrial biopsy (EB)) was conducted between December 2015 and August 2017 and included women ≥45 years of age presenting with abnormal uterine bleeding, postmenopausal bleeding, or thickened endometrial stripe. Patients rated pain after each sampling procedure using a 100-point visual analog scale (VAS). RESULTS: Of 428 enrolled, 190 (44.39%) patients underwent all 3 sampling methods and reported a VAS score for each. Nearly half were postmenopausal (n = 93, 48.9%); the majority were parous (172, 90.5%) of which 87.8% had at least one vaginal delivery. Among the 190 patients, the median (IQR) pain score was significantly lower for sampling via tampon (0 [0,2]) compared to TB (28 [12, 52]) or EB (32 [15, 60]) (both p < 0.001, Wilcoxon signed rank test). Among women who underwent tampon sampling, age and pain scores showed a weak positive correlation (Spearman rank correlation, r = 0.14; p = 0.006); EB sampling was associated with a weak inverse correlation between parity and pain scores (r = -0.14; p = 0.016). CONCLUSION: Gynecologic tract sampling using a tampon had significantly lower pain than both EB and TB. Pain with tampon sampling was positively correlated with age and pain with EB sampling was inversely correlated with parity. Pain scores for TB and EB were not significantly related to age, menopausal status, or BMI.

Assessment of four pain scales for evaluating procedural pain in premature infants undergoing heel blood collection.

BACKGROUND: Procedural pain is underestimated in hospitalized preterm infants. The aim of this study was to assess the reliability, validity, and clinical utility of the Neonatal Facial Coding System (NFCS), Douleur Aiguë du Nouveau-né (DAN) scale, Neonatal Infant Pain Scale (NIPS), and Premature Infant Pain Profile (PIPP) in premature infants undergoing heel blood collection. We assume that the four scales were similar in reliablility and validity (but different in clinical utility). METHODS: The pain assessments were performed on 111 premature infants using the four scales. Internal consistency was determined by Cronbach's α, and the reliability was determined by the intraclass correlation coefficients. Concurrent validity was evaluated by Spearman's rank correlations. Bland-Altman plots were used to investigate the convergent validity. RESULTS: The internal consistency and their reliability of the scales were high (p < 0.001). Scores were significantly higher at the time of blood collection (p < 0.001). Mean scores of clinical utility of PIPP were significantly higher than NFCS and DAN (p < 0.05) but not higher than the NIPS (p > 0.05). CONCLUSIONS: The four scales were reliable and valid. This study suggests that the PIPP and NIPS has good clinical utility and are better choice for evaluating procedural pain in premature infants. IMPACT: The aim of this study was to assess the reliability, validity, and clinical utility of NFCS, DAN, NIPS, and PIPP in premature infants undergoing heel blood collection. The results showed that the four scales have high reliability and internal consistency; the PIPP and NIPS have good clinical utility and are better choice for evaluating procedural pain in premature infants. Our study results provided a reference for clinical workers in choosing pain assessment scales and conduction intervention.

Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination.

BACKGROUND: Intentional endometrial injury is being proposed as a technique to improve the probability of pregnancy in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF). Endometrial injury is often performed by pipelle biopsy and is a common gynaecological procedure with established safety. However, it causes a moderate degree of discomfort/pain and requires an additional pelvic examination. The effectiveness of this procedure outside of ART, in women or couples attempting to conceive via sexual intercourse or with intrauterine insemination (IUI), remains unclear. OBJECTIVES: To assess the effectiveness and safety of intentional endometrial injury performed in infertile women or couples attempting to conceive through sexual intercourse or intrauterine insemination (IUI). SEARCH METHODS: The Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Knowledge, and clinical trial registries were searched from inception to 21 May 2020, as were conference abstracts and reference lists of relevant reviews and included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that evaluated any kind of intentional endometrial injury in women planning to undergo IUI or attempting to conceive spontaneously (with or without ovarian stimulation (OS)) compared to no intervention, a mock intervention, or intentional endometrial injury performed at a different time or to a higher/lower degree. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. Primary outcomes were live birth/ongoing pregnancy and pain experienced during the procedure. Due to high risk of bias associated with many of the studies, primary analyses of all review outcomes were restricted to studies at low risk of bias. Sensitivity analysis including all studies was then performed. MAIN RESULTS: We included 23 RCTs (4035 women). Most of these studies included women with unexplained infertility. Intentional endometrial injury versus either no intervention or a sham procedure The primary analysis was restricted to studies at low risk of bias, which left only one study included. We are uncertain whether endometrial injury has an effect on the probability of live birth, as only one study is included in the analysis and the confidence interval is wide (risk ratio (RR) 1.11, 95% confidence interval (CI) 0.78 to 1.59; 1 RCT, 210 participants). Evidence suggests that if the chance of live birth with no intervention/a sham procedure is assumed to be 34%, then the chance with endometrial injury would be 27% to 55%. When all studies were included in the sensitivity analysis, we were uncertain whether endometrial injury improves live birth/ongoing pregnancy, as the evidence was of very low quality (RR 1.71, 95% CI 1.32 to 2.21; 8 RCTs, 1522 participants; I² = 16%). Evidence suggests that if the chance of live birth/ongoing pregnancy with no intervention/a sham procedure is assumed to be 13%, then the chance with endometrial injury would be 17% to 28%. A narrative synthesis conducted for the other primary outcome of pain during the procedure included studies measuring pain on a zero-to-ten visual analogue scale (VAS) or grading pain as mild/moderate/severe, and showed that most often mild to moderate pain was reported (6 RCTs, 911 participants; very low-quality evidence). Higher versus lower degree of intentional endometrial injury Evidence was insufficient to show whether there is a difference in ongoing pregnancy rates (RR 1.29, 95% CI 0.71 to 2.35; 1 RCT, 332 participants; low-quality evidence) between hysteroscopy with endometrial injury and hysteroscopy alone. Evidence suggests that if the chance of ongoing pregnancy with hysteroscopy alone is 10%, then the chance with hysteroscopy with endometrial injury would be 7% to 24%. This study did not report the primary outcomes of live birth and pain during the procedure. Timing of intentional endometrial injury Four trials compared endometrial injury performed in the cycle before IUI to that performed in the same cycle as IUI. None of these studies reported the primary outcomes of live birth/ongoing pregnancy and pain during the procedure. One study compared endometrial injury in the early follicular phase (EFP; Day 2 to 4) to endometrial injury in the late follicular phase (LFP; Day 7 to 9), both in the same cycle as IUI. The primary outcome live birth/ongoing pregnancy was not reported, but the study did report the other primary outcome of pain during the procedure assessed by a zero-to-ten VAS. The average pain score was 3.67 (standard deviation (SD) 0.7) when endometrial injury was performed in the EFP and 3.84 (SD 0.96) when endometrial injury was performed in the LFP. The mean difference was -0.17, suggesting that on average, women undergoing endometrial injury in the EFP scored 0.17 points lower on the VAS as compared to women undergoing endometrial injury in the LFP (95% CI -0.48 to 0.14; 1 RCT, 110 participants; very low-quality evidence). AUTHORS' CONCLUSIONS: Evidence is insufficient to show whether there is a difference in live birth/ongoing pregnancy between endometrial injury and no intervention/a sham procedure in women undergoing IUI or attempting to conceive via sexual intercourse. The pooled results should be interpreted with caution, as the evidence was of low to very low quality due to high risk of bias present in most included studies and an overall low level of precision. Furthermore, studies investigating the effect of timing of endometrial injury did not report the outcome live birth/ongoing pregnancy; therefore no conclusions could be drawn for this outcome. Further well-conducted RCTs that recruit large numbers of participants and minimise bias are required to confirm or refute these findings. Current evidence is insufficient to support routine use of endometrial injury in women undergoing IUI or attempting to conceive via sexual intercourse.

Anesthetic management for cesarean delivery in a woman with congenital atlantoaxial dislocation and Chiari type I anomaly: a case report and literature review.

BACKGROUND: The preferable choice of anesthesia for the patients with congenital atlantoaxial dislocation (CAAD) and type I Arnold Chiari malformations (ACM-I) has been a very confusing issue in clinical practice. We describe the successful administration of combined spinal-epidural anesthesia for a woman with CAAD and ACM-1 accompanied by syringomyelia. CASE PRESENTATION: Our case report presents the successful management of a challenging obstetric patient with CAAD and ACM-1 accompanied by syringomyelia. She had high risks of difficult airway and aspiration. The injection of bolus drugs through the spinal or epidural needle may worsen the previous neurological complications. The patient was well evaluated with a multidisciplinary technique before surgery and the anesthesia was provided by a skilled anesthesiologist with slow spinal injection. CONCLUSIONS: An interdisciplinary team approach is needed to weigh risks and benefits for patients with CAAD and ACM-1 undergoing cesarean delivery. Therefore, an individual anesthetic plan should be made basing on the available anesthetic equipments and physicians' clinical experience on anesthetic techniques.

Effectiveness of lidocaine spray on radial arterial puncture pain: A randomized double-blind placebo controlled trial.

OBJECTIVE: Radial arterial puncture is a painful procedure. The aim of this study was to evaluate the effect of lidocaine spray (10%) on pain associated with radial artery blood withdrawal for arterial blood gas analysis. METHODS: This randomized, controlled, double-blind study was performed between December 2018 and September 2019. Before radial arterial puncture, 10% lidocaine or placebo spray was applied to each patient by the attending physician, who was blinded with regard to random assignment. The spray was administered six times on the site from a distance of 5 cm. After waiting for 5 min, a radial arterial puncture was performed routinely. The pain levels of patients during radial arterial puncture and 5 min after puncture were evaluated with the visual analog scale (VAS). The Wilcoxon test was used to compare pain scores during puncture. RESULTS: The research was performed with 67 patients (34 patients in the lidocaine group, 33 patients in the placebo group) who were admitted to the emergency department and required ABG analysis. Forty-three patients were men, and 24 were women. The ages of the patients ranged between 19 and 86 years, and the mean (± standard deviation) age was 56.3 ± 16.6 years. Pain levels, as measured by VAS, were significantly lower in the lidocaine group (24.00 mm IQR:[14.75-33.75]) compared with the placebo group (33.00 mm IQR:[22.00-61.50]) during radial arterial puncture (p = 0.011). CONCLUSIONS: The level of pain perceived during radial arterial puncture was significantly lower in those who were administered lidocaine spray. Lidocaine spray application can be used in pain management related to radial arterial puncture.

Topical ketamine as a local anesthetic agent in reducing venipuncture pain: A randomized controlled trial.

AIM: Pain control is an important aspect of ED patient management, and there are many different protocols used around the world influenced by both availability of local resources as well as staff competency and experience. This study aims to evaluate the use of topical ketamine in acute pain reduction by directly comparing it to lidocaine-prilocaine (EMLA) cream. MATERIALS AND METHODS: In this randomized clinical trial, 300 adult patients classified as level 4 or 5 by ESI triage system were enrolled. These patients were divided randomly into three groups. The site of venipuncture was covered with 2 g of topical ketamine cream 10% in group one, 2 g of 5% EMLA cream in group two, and finally, in group 3 (control group), was covered with placebo (2 g of cold cream). The primary end point of the study was reported pain severity with secondary end points being onset of local anesthesia as well as any side effects noted. RESULTS: The data gathered showed pain score during venipuncture in both intervention groups were significantly lower when compared to the control group (P < 0.05). However, pain score did not differ between the 2 intervention groups (P = 0.395). There was no statistically significant difference between the ketamine or EMLA in onset of local anesthesia (P = 0.419). We noted itching and irritation was significantly higher in the EMLA group when compared to ketamine(P < 0.05). CONCLUSION: This study showed that local cutaneous ketamine is as effective as EMLA in relieving pain during venipuncture.

Randomized, Placebo-Controlled Phase 1/2 Study to Determine the Appropriate ATX-101 Concentration for Reduction of Submental Fat.

BACKGROUND: ATX-101 is indicated for submental fat treatment. OBJECTIVE: Evaluate ATX-101 versus placebo for reducing submental fat. MATERIALS AND METHODS: Adults with unwanted submental fat across 6 global sites were randomized to ATX-101 (0.5%, 1.0%, or 2.0%) or placebo for ≤4 treatments every 28 days. Outcomes included safety (adverse events and pain visual analog scale) throughout the study and efficacy (submental fat rating, patient satisfaction, and submental fat improvements) at Week 16. RESULTS: Eighty-four of 85 enrolled patients received ≥1 ATX-101 treatment (0.5% [n = 20], 1.0% [n = 20], 2.0% [n = 22] or placebo [n = 22]). Most patients (n = 82) experienced adverse events, which were mostly mild/moderate, seemed to be dose-related, and led to no study discontinuations. The mean pain scores were highest in the ATX-101 1.0% and 2.0% groups. Week-16 change from baseline in the submental fat rating scale was significantly greater for ATX-101 0.5% and 1.0% versus placebo (p ≤ .05). At Week 16, 71%, 74%, 53%, and 40% of patients in the ATX-101 0.5%, 1.0%, 2.0%, and placebo groups, respectively, achieved a ≥1-grade reduction in submental fat from baseline. Satisfaction with appearance and patient-assessed global improvement ratings increased in all ATX-101 treatment groups versus placebo. CONCLUSION: All ATX-101 concentrations were safe and efficacious for moderate/severe submental fat reduction.

Comparison Between Cyanoacrylate Embolization and Radiofrequency Ablation for Superficial Venous Incompetence: A Systematic Review and Meta-analysis.

BACKGROUND: Chronic venous disease is a debilitating condition involving great saphenous vein (GSV) incompetence. OBJECTIVE: To investigate the efficacy and effectiveness of cyanoacrylate embolization (CAE) versus radiofrequency ablation (RFA) in patients with incompetent GSVs. MATERIALS AND METHODS: PubMed, Embase, and the Cochrane library were searched. The primary outcomes were the Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), closure rate, and visual analog scale (VAS) for pain. RESULTS: This meta-analysis included 378 and 590 patients who underwent CAE and RFA, respectively. Cyanoacrylate embolization was comparable with RFA in VCSS (weighted mean difference [WMD] = -0.03, 95% confidence interval [CI]: -0.18 to 0.12, p = .686), AVVQ (WMD = -0.08, 95% CI: -0.38 to 0.21, p = .570), closure rate (odds ratio [OR] = 0.61, 95% CI: 0.18-2.01, p = .414), and VAS (standardized mean difference [SMD] = 0.24, 95% CI: -0.59 to 1.06, p = .523). There were no significant differences between CAE and RFA regarding the occurrence of phlebitis (OR = 1.22, 95% CI: 0.70-2.13, p = .479) and pigmentation (OR = 0.48, 95% CI: 0.18-1.31, p = .153), but CAE had a lower risk of ecchymosis (OR = 0.45, 95% CI: 0.25-0.81, p = .007) and paresthesia (OR = 0.16, 95% CI: 0.03-0.99, p = .049). CONCLUSION: Cyanoacrylate embolization and RFA demonstrated no significant differences in VCSS, AVVQ, closure rate, and pain score for patients with incompetent GSVs. Patients in the CAE group had a lower risk of ecchymosis and paresthesia compared with the RFA group.

Newborn Infant Parasympathetic Evaluation Index for the Assessment of Procedural Pain in Nonanesthetized Infants: A Multicenter Pilot Study.

OBJECTIVE: The aim of this study is to evaluate the ability of the Newborn Infant Parasympathetic Evaluation (NIPE) index to detect the response to nociceptive stimuli in nonanesthetized infants and to compare these results to simultaneous scoring by behavioral scales. STUDY DESIGN: Thirty-six nonanesthetized infants admitted to neonatal/pediatric intensive care unit (N/PICUs) were enrolled to the study. Due to faulty records of the data, three patients had to be excluded. To detect pain caused by noxious stimuli, the heart-rate-variability-derived NIPE index and behavioral pain scales designed for measuring procedural pain in nonverbal children were used. RESULTS: Forty-one painful events were available for analysis. We observed in the whole group a statistically significant decrease in NIPE values at 1, 2, and 3 minutes after a painful stimulus, in comparison to the NIPE value at rest and the statistically significant differences between the minimum NIPE value within 3 minutes after the stimulus in comparison to NIPE value at rest in the whole group, as well as in the subgroups of moderate and severe pain. Receiver operating characteristic (ROC) analysis has shown the strong sensitivity and specificity of the NIPE in detecting the noxious stimuli (ROC AUC: 0.767). We also found that the stronger the sensation of pain was, the more rapidly NIPE reached its lowest value. DISCUSSION: Our study indicates that the painful procedures are associated with a significant decrease in the NIPE value within 3 minutes after a noxious stimulus. Based on our observation, the minimum value within 3 minutes from the painful procedure seems to be the most distinctive value.

The Psychometric Properties of the Visual Analogue Scale Applied by an Observer to Assess Procedural Pain in Infants and Young Children: An Observational Study.

PURPOSE: The Visual Analogue Scale applied by an observer (VASobs) is widely used to quantify pain but the evidence to support validity is poor. The aim of this study was to evaluate the psychometric and practical properties of the VASobs used to assess procedural pain in infants and young children. DESIGN AND METHODS: In an observational study, 26 clinicians applied the VASobs independently to video segments of 100 children aged six to 42 months undergoing a procedure to generate pain and distress scores. Each video segment was scored by four randomly selected reviewers. RESULTS: Reliability for pain scores was poor to fair (ICC 0.35 to 0.55) but higher for distress scores (ICC 0.6 to 0.89). At a cut-off score of 3, sensitivity and specificity were 84.7% and 95.0%, respectively for pain and 91.5% and 77.5% respectively for distress. Linear mixed modelling confirmed responsiveness. An increase in pain scores (regression slope 4.95) and distress scores (regression slope 5.52) across phases (baseline to procedure) was seen for painful procedures. The correlation between VASobs pain and FLACC scores was good (r = 0.74) and correlations between VASobs distress and FLACC scores were excellent (r = 0.89). CONCLUSION: VASobs was easily applied and preferred by clinicians. Despite evidence of sensitivity and responsiveness to pain, the reliability results were poor, and this scale cannot be recommended for use. PRACTICE IMPLICATIONS: The results of this study prevent recommending the VASobs for assessing procedural pain in infants and young children for clinical or research purposes.

Subcapsular local anesthesia approach in percutaneous liver biopsy: less pain, more comfort

Background/aim: To compare the subjective level of pain in patients who underwent an ultrasound-guided percutaneous liver biopsy (PLB) after either pericapsular anesthesia (PA) or subcapsular anesthesia (SA), based on the numeric rating scale (NRS). Materials and methods: A total of 323 patients, mean age 51, range 21­82 years; 160 (49.5%) male, referred to the Interventional Radiology Clinic of Kocaeli University Faculty of Medicine for image-guided PLB, between June 2019 and May 2020 were included and randomized into two groups by anesthetic type; the first (n = 171) consisted of patients undergoing SA while the second (n = 152) included patients undergoing PA. The intensity of pain at 0, 1, and 6 h after PLB was evaluated between the groups using NRS. Results: At hours 0, 1, and 6, the median [range] NRS scores in the subcapsular and pericapsular groups were 2 [1­2] versus 3 [2­4] (P < 0.001), 1 [0­1] versus 1 [1­2] (P < 0.001), and 0 [0­0] versus 1 [0­1] (P < 0.001), respectively. Subgroup analysis revealed that the patients who underwent the subcostal procedure with subcapsular anesthesia reported the lowest pain scores and intercostal procedure with pericapsular anesthesia reported the worst pain scores for each time point: 0 h 1 [1­2] versus 3 [3­4], P < 0.001; 1 h 1 [0­1] versus 1 [1­2], P < 0.001; and 6 h 0 [0­0] versus 0 [0­1], P < 0.001, respectively. Conclusion: Subcapsular anesthesia is a well-tolerated procedure compared to a pericapsular procedure. Furthermore, the application of a subcapsular anesthetic with a subcostal approach was reported to result in the lowest pain and greatest patient comfort.

A Prospective Randomized Controlled Trial of Irrigation "Bag Squeeze" to Manage Pain for Patients Undergoing Flexible Cystoscopy.

PURPOSE: We determined if the "bag squeeze" technique decreases pain during flexible cystoscopy in men. MATERIALS AND METHODS: This single center, prospective, double-blind, randomized controlled trial recruited 200 consenting participants who were ambulatory, outpatient males who had undergone prior cystoscopy and were not expected to require any secondary procedures. Men with prior urethral stricture or bladder neck contracture were excluded from study. Once eligibility was assessed and consent obtained, participants were randomized to undergo cystoscopy with the bag squeeze (group A) or the sham bag squeeze procedure (group B). Following cystoscopy, participants completed a pain questionnaire (visual analogue scale). Differences in mean pain score between groups were evaluated using Students' t-test with a 2-sided alpha of 0.05. RESULTS: A total of 200 patients were randomized and underwent flexible cystoscopy. Ten participants were ineligible because they required secondary procedures. Among the 190 eligible patients 97 were randomized to bag squeeze (group A) and 93 to sham bag squeeze (group B) with mean pain scores of 1.91 and 3.39, respectively (p <0.005). CONCLUSIONS: This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation bag squeeze technique was used vs placebo bag squeeze. Accordingly, this useful, simple and free method to improve patient comfort during flexible cystoscopy should be adopted by clinicians.