Evaluation of EMLA cream with microneedle patches in palatal anesthesia in children: a randomized controlled clinical trial.

Palatal injections are considered to be one of the most painful dental procedures. As a result, it was important to find alternatives to this painful injection to improve children's cooperation. The dental literature mentioned using EMLA cream as a possible alternative to conventional injections, but its anesthetic effect was debated. Therefore, it was valuable to research the impact of microneedle patches to enhance the effectiveness of this cream. The purpose of this randomized controlled clinical trial was to compare the effectiveness of different methods of anesthesia and pain levels in children aged 7-11 years. The study compared the use of EMLA cream, EMLA with microneedles, and conventional palatal injections. A total of 90 children were randomly assigned to three groups: Group 1 received conventional palatal anesthesia (control), Group 2 received EMLA cream only, and Group 3 received EMLA with microneedles. Pain levels were assessed using the FLACC and Wong-Baker scales at three different time points: T1(during anesthesia), T2(on palatal probing), and T3(during extraction). The FLACC scale revealed a significant difference in pain between groups only at T1 (P value = 0.000). It was found that the conventional palatal injection group had a higher pain level than the EMLA cream-only group and the group using microneedle patches with EMLA cream (P value = 0.000). However, the other groups did not show significant differences in pain levels during the anesthesia (P value = 1.00). Similarly, the Wong-Baker scale also demonstrated a statistically significant difference in pain between groups only at T1 (P value = 0.000). It was found that the conventional palatal injection group had a higher pain level than the EMLA cream-only group and the group using microneedle patches with EMLA cream (P value = 0.000). However, the other groups did not show significant differences in pain levels during the anesthesia (P value = 0.091). The study concludes that both EMLA cream alone and EMLA with microneedles can be used as an alternative to conventional palatal anesthesia for children.

Safety and Pharmacokinetics of PSD502 in Healthy Chinese Male and Female Volunteers: Two Randomized, Double-Blind, Placebo-Controlled, Phase I Trials.

BACKGROUND AND OBJECTIVE: PSD502 is a metered-dose spray for premature ejaculation. The two trials aimed to evaluate the safety and pharmacokinetics of PSD502 in healthy Chinese male and female individuals. METHODS: Two phase I, randomized, double-blind, placebo-controlled trials were conducted in men (Trial 1) and women (Trial 2). The participants were randomized 3:1 to receive PSD502 (7.5 mg of lidocaine and 2.5 mg of prilocaine per spray) or a placebo. For male individuals, a single dose (three sprays) once daily was applied to the glans penis for 21 days except for nine sprays (three doses) on days 7 and 14, 4 h apart for each dose. For female individuals, two sprays were applied to the vagina and one to the cervix once daily for 7 days. The primary endpoint was safety. Pharmacokinetics analysis was also performed. RESULTS: Twenty-four male and 24 female individuals were recruited. Treatment-emergent adverse events occurred in 38.9% (7/18) of male individuals and 66.7% (12/18) of female individuals in the PSD502 group, respectively. Both trials reported 50.0% (3/6) treatment-emergent adverse events for the placebo. No grade ≥ 3 treatment-emergent adverse events, serious adverse events, or treatment-emergent adverse events leading to early withdrawal or discontinuation occurred. After consecutive applications, lidocaine and prilocaine cleared rapidly in both trials. Plasma concentrations exhibited high inter-individual variability. The maximum plasma concentrations of active ingredients were far below the anticipated minimum toxic concentrations. The area under the plasma concentration-time curve of metabolites were ≤ 20% of the parent drugs. No clinically significant accumulations were observed in the two trials. CONCLUSIONS: PSD502 was well tolerated and showed low plasma concentrations in healthy Chinese male and female individuals.

Cutoff criteria for the placebo response: a cluster and machine learning analysis of placebo analgesia.

Computations of placebo effects are essential in randomized controlled trials (RCTs) for separating the specific effects of treatments from unspecific effects associated with the therapeutic intervention. Thus, the identification of placebo responders is important for testing the efficacy of treatments and drugs. The present study uses data from an experimental study on placebo analgesia to suggest a statistical procedure to separate placebo responders from nonresponders and suggests cutoff values for when responses to placebo treatment are large enough to be separated from reported symptom changes in a no-treatment condition. Unsupervised cluster analysis was used to classify responders and nonresponders, and logistic regression implemented in machine learning was used to obtain cutoff values for placebo analgesic responses. The results showed that placebo responders can be statistically separated from nonresponders by cluster analysis and machine learning classification, and this procedure is potentially useful in other fields for the identification of responders to a treatment.

Effect of Topical Analgesia on Desensitization Following 8% Topical Capsaicin Application.

To prevent pain associated with 8% capsaicin application, pretreatment with local anesthetics, such as EMLA (eutectic mixture of lidocaine 2.5% and prilocaine 2.5%), is considered an option. However, there is contradicting evidence regarding the effects of local analgesia on capsaicin-induced desensitization. In session 1, 2 skin areas in each forearm of 24 healthy volunteers were randomized to 2-hour pretreatment with EMLA/placebo cream. After pretreatment, 8% capsaicin patches were applied for 3 hours in 1 placebo and 1 EMLA pretreated area, obtaining the following four areas: Capsaicin + EMLA, Capsaicin + Placebo, EMLA alone, and Placebo. Pain intensity scores were assessed during the 3-hour application of capsaicin. Warmth detection, heat pain sensitivity, and microvascular reactivity were measured after the removal of capsaicin. After 24 hours, in session 2, all tests were repeated followed by histamine application in each area to examine itch intensity and neurogenic flare. Overall, EMLA caused significant reductions in capsaicin-induced pain compared with placebo (P= .007) and enhanced the capsaicin-induced increase in superficial blood perfusion immediately after the 3-hour capsaicin application (P< .01). Regardless of pretreatment, capsaicin induced heat hyperalgesia immediately after the application (P< .001). Twenty-four hours post application, heat pain sensitivity was normalized. However, WDT increased significantly (P< .001). Capsaicin tended to reduce the itch intensity and significantly reduced the neurogenic flare (P< .05) induced by histamine compared with EMLA alone. The findings suggest that pretreatment with topical analgesic cream reduces application site pain without interfering with the 8% topical capsaicin-induced desensitization. PERSPECTIVE: Pretreatment with local anesthetic EMLA cream might be considered a good therapeutic option to reduce the pain associated with 8% capsaicin application currently used for treatment of neuropathic pain syndromes. This study also suggests the existence of a synergistic effect of capsaicin and EMLA on the process of neurogenic inflammation.

Postinflammatory Hyperpigmentation following Electrodesiccation with a Eutectic Mixture of Local Anesthetics.

We assessed the effects of prior application of a eutectic mixture of local anesthetics (EMLA) on the appearance of dyschromia at the site of superficial electrodesiccation in an observer-blind, case-control study in 60 patients. Thirty subjects each were assigned to Groups A and B; both groups underwent radiofrequency (RFC) ablation for facial dermatosis papulosa nigrans (DPN). Group A received RFC ablation with prior application of EMLA, whereas Group B did not. No significant difference was observed in the dyschromia between both groups. EMLA cream was well tolerated by the study participants. (SKINmed. 2020;18:222-225).

Eutectic mixture of local anaesthetics for pain reduction during extracorporeal shockwave lithotripsy: A systematic review and meta-analysis.

A systematic review and meta-analysis was conducted to explore the effect of a eutectic mixture of local anaesthetics (EMLA) on pain reduction during extracorporeal shockwave lithotripsy (ESWL). PubMed, Web of Science, Embase, EBSCO, and Cochrane library databases (updated March 2020) were searched for randomised controlled trials (RCTs) assessing the effect of EMLA for patients that underwent ESWL. The search strategy and study selection process were managed according to the PRISMA statement. Six RCTs were included in the meta-analysis. Overall, the results indicated that EMLA significantly reduced pain compared to the control group (RR = -2.98, 95% CI = -5.82 to -0.13, P = 0.04) with a heterogeneity of I2 = 57% (P = 0.04). Subgroup analysis showed that EMLA did not significantly reduce pain when the patients took an analgesic premedication (RR = -1.46, 95% CI = -5.89 to 2.98, P = 0.52) with a heterogeneity of I2 = 38% (P = 0.52). Conversely, studies without premedication showed a significant pain relief effect (RR = -4.08, 95% CI = -7.36 to -0.65, P = -0.80) with a heterogeneity of I2 = 48% (P = 0.14). Most studies showed there was no difference in the patient's need for analgesics. EMLA was effective for reducing pain during EWSL. However, this analgesic effect was limited and did not reduce the need for analgesics.

Comparison of the efficacy of two different local anesthetics in inferior turbinate reduction.

PURPOSE: The present study compares the local anesthetic efficacy of EMLA® cream and lidocaine injection used in the radiofrequency reduction of the inferior turbinate. METHODS: The study included a total of 124 patients with inferior turbinate hypertrophy and who underwent turbinate reduction under local anesthesia. The operations were performed 15 min after a lidocaine injection and 30 min after EMLA cream application. The respondent patients were asked to interpret such situations as intraoperative pain, discomfort during the procedure, choking sensation and difficulty swallowing using the Visual Analogue Scale (VAS). RESULTS: The EMLA cream patients (Group A) were found to have a lower level of discomfort, choking sensation and difficulty swallowing than the lidocaine patients (Group B), while there was no substantial difference in pain between the two groups. CONCLUSIONS: It is concluded that EMLA® cream is an effective alternative to lidocaine injection during inferior turbinate reduction procedures.

Influence of Topical Anesthesia on Superficial Sensitivity: A Double-Blind, Randomized, Placebo-Controlled Study on 48 Healthy Subjects.

BACKGROUND: Topical anesthetics are used in noninvasive transdermal anesthesia to decrease the superficial pain sensation threshold during dermatologic surgery. Combined pain relief and sensitivity loss can avoid discomfort during the surgery. OBJECTIVE: The aim of this placebo-controlled study was to compare the efficacy of 3 commonly used topical agents by collating loss of sensitivity over time. MATERIALS AND METHODS: Three topical anesthetic creams, a topical anti-inflammatory cream, and a moisturizing cream were applied on the left volar forearm of each of the 48 healthy Caucasian participants. Sensitivity was assessed with the dynamic 2-point discrimination and the Semmes-Weinstein test at 0, 60, 90, 120, 150, and 180 minutes after cream application. RESULTS: After 180 minutes, benzocaine showed a significantly lower 2-point discrimination reduction than lidocaine alone and a lidocaine and prilocaine mixture. Sensory threshold measurements by the Semmes-Weinstein test after 60 minutes revealed a significantly higher effect with lidocaine alone and with the lidocaine and prilocaine mixture than with benzocaine. CONCLUSION: The authors found a stronger skin sensitivity reduction by the eutectic lidocaine and prilocaine mixture and lidocaine alone compared with benzocaine. We suggest increased discomfort reduction in topical anesthetic supported dermatologic surgery by the eutectic mixture and lidocaine alone.

Comparison of the pain-reducing effects of EMLA cream and of lidocaine tape during arteriovenous fistula puncture in patients undergoing hemodialysis: A multi-center, open-label, randomized crossover trial.

Arteriovenous fistula puncture pain is a serious problem for patients undergoing dialysis and a good indication for topical anesthetics. No previous study has compared lidocaine/prilocaine cream (EMLA) with lidocaine tape for pain relief during arteriovenous fistula puncture in patients undergoing maintenance hemodialysis. To this end, we conducted a multicenter randomized crossover study including 66 patients (mean age, 65.8 years; males, 57.6%) undergoing maintenance hemodialysis thrice/week. Subjects were assigned to Sequence EL (EMLA administration followed by lidocaine, with 1-week wash-out) or Sequence LE (reverse administration, first lidocaine then EMLA). All subjects completed the study. At each puncture site, 1 g EMLA (25 mg lidocaine + 25 mg prilocaine) or one sheet of lidocaine tape (18 mg lidocaine) was applied 1 h or 30 min prior to arteriovenous fistula puncture, respectively. The primary endpoint was puncture pain relief, which was measured using a 100-mm visual analog scale. The secondary endpoints included quality of life, which was measured by SF-36, and safety. EMLA produced a 10.1-mm greater visual analog scale improvement than lidocaine tape (P = 0.00001). However, there was no statistically significant difference in the quality of life between the two groups, and no significant carryover/period effect was observed in any analysis. Further, no drug-related adverse events were observed. Taken together, these results suggest that EMLA cream is superior to lidocaine tape for the relief of arteriovenous fistula puncture pain in patients undergoing maintenance hemodialysis. Trial registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN000027885).

Lidocaine-prilocaine cream versus local infiltration anesthesia in pain relief during repair of perineal trauma after vaginal delivery: a systematic review and meta-analysis.

Background: Perineal trauma is a common problem that may affect women during vaginal delivery; this trauma can be either spontaneous (tear) or intentional (episiotomy). When repair of perineal trauma is required, adequate analgesics must be obtained. Topical products as lidocaine-prilocaine (EMLA) cream is one of the suggested methods, but still there is lack of evidence with regard to its efficacy and safety.Objective: The aim of this review is to assess the evidence of utilizing EMLA cream in comparison to local perineal infiltration anesthesia for pain control during perineal repair after vaginal delivery.Data sources: Medline, Embase, Dynamed Plus, ScienceDirect, TRIP database, ClinicalTrials.gov and the Cochrane Library were searched electronically from January 2006 to May 2018 for studies investigating the effect of lidocaine-prilocaine cream in relieving pain during repair of perineal trauma.Methods of study selection: All randomized controlled trials assessing effect of lidocaine-prilocaine cream versus local infiltration anesthesia in relieving pain during repair of perineal trauma were considered for this meta-analysis. Fifteen studies were identified of which four studies deemed eligible for this review. Quality and risk of bias assessment was performed for all studies.Data extraction: Two researchers independently extracted the data from the individual articles and entered into RevMan software. The weighted mean difference (WMD) and 95% confidence interval (CI) was calculated. Statistical heterogeneity between studies was assessed by the Higgins chi-square and (I2) statistics. When heterogeneity was significant, a random-effects model was used for meta-analysis. Otherwise, the fixed effect meta-analysis was used when there was no significant heterogeneity.Results: Pooled analysis of result in "pain score" was insignificant between the two groups (WMD -1.11; 95% CI (-2.55 to 0.33); p = .13). Furthermore, the use of additional analgesia showed no statistically significant difference between the two groups (WMD 1.34; 95% CI (0.66-2.71), p = .42). Regarding patient satisfaction, an overall analysis of three studies showed significant results favoring EMLA cream group users (WMD 4.65; 95% CI (1.96-11.03), p = .0005). The pooled analysis of the outcome "duration of repair" showed the significantly shorter duration of repair in EMLA cream users (n = 92) than local infiltration anesthesia (n = 95) (1.72 min; 95% CI (-2.76 to -0.67), p = .001).Conclusions: This meta-analysis suggests that topical lidocaine-prilocaine cream gives comparable results in reducing pain during perineal repair after vaginal delivery.

Lidocaine-Propitocain Cream, a Eutectic Mixture of Local Anesthetics, Effectively Relieves Pain Associated With Vascular Access Intervention Therapy in Patients Undergoing Hemodialysis: A Placebo-Controlled, Double-Blind, Crossover Study.

Vascular access intervention therapy (VAIVT) is necessary to maintain vascular access in patients undergoing hemodialysis. VAIVT-associated vasodilatation is painful. However, few reports have focused on effective pain relief at the time of VAIVT. The present study was performed to determine whether lidocaine-propitocain cream, a eutectic mixture of local anesthetics (EMLA), effectively reduces VAIVT-associated pain in patients undergoing hemodialysis. This placebo-controlled, double-blind, crossover study was conducted in a single center. Among 210 patients who underwent a total of 437 VAIVT procedures from August 2017 to June 2018, 30 patients were randomly allocated to either the EMLA-placebo arm or placebo-EMLA arm at the time of VAIVT. EMLA application significantly reduced the visual analog scale score compared with placebo (47.0 ± 21.1 vs. 68.6 ± 20.7 mm, respectively; P < 0.05). EMLA is a safe and effective treatment for relief of VAIVT-associated pain in patients undergoing hemodialysis.

Lidocaine-Epinephrine-Tetracaine Gel Is More Efficient than Eutectic Mixture of Local Anesthetics and Mepivacaine Injection for Pain Control during Skin Repair in Children: A Prospective, Propensity Score Matched Two-Center Study.

INTRODUCTION: Skin lacerations are common in children and their repair is a very unpleasant experience for a child. While pain management has been recognized as a key element of high-quality patient care, recent studies report that pain management in the pediatric emergency departments is still suboptimal. Lidocaine-epinephrine-tetracaine (LET) gel could potentially improve the traumatic experience caused by skin repair as it obviates the need for infiltration. Thus, the aim of the current study was to compare local eutectic mixture of local anesthetics (EMLA) plus mepivacaine infiltration with topical anesthetics (LET-gel). MATERIALS AND METHODS: Prospective, propensity score-matched multicenter study including all children between 3 and 16 years presented at two centers. After anesthetics (LET vs. EMLA and infiltration) standardized skin repair was performed. Pain assessment was performed using the faces pain rating scale or visual analogue scale. Follow-up, performed 2 weeks after initial presentation, assessed wound infection rates and overall satisfaction. RESULTS: Of 73 subjects 59 children (37 LET vs. 22 EMLA) were included after propensity score matching. Groups had similar baseline characteristics. Pretreatment was significantly less painful in LET versus local anesthetics group. Pain during skin repair was similar between groups (LET and EMLA with mepivacaine infiltration) and both groups demonstrated similar efficacy (procedure time, need for secondary infiltration, infection rate). Ultimately, pain levels during pretreatment and the surgical procedure were perceived significantly higher by the children than estimated by parents or surgeons. CONCLUSION: In conclusion, it appears that LET is superior to conventional anesthesia including mepivacaine infiltration in the pediatric emergency departments. Pretreatment with LET is significantly less painful but equally effective. Hence, we recommend LET as a topical anesthetic in the pediatric emergency department.

Local dermal application of a compound lidocaine cream in pain management of cancer wounds.

The aim of this study was to explore the analgesic effect of local application of compound lidocaine/prilocaine cream on cancer wounds during wound care in order to reduce the amount of morphine intake or completely replace the systemic morphine administration and optimize the protocol for cancer wound pain management. All patients were enrolled with a visual analog scale (VAS) pain score ≥4. Before wound care, 60 patients were randomly divided into 2 groups of 30 each: morphine group (10 mg tablet); topical 5% compound lidocaine cream group (0.2 g/cm2). VAS scores, heart rate, and Kolcaba comfort level were recorded for the two groups 10 min before and 10, 15, 20, and 25 min after wound care and data were analyzed statistically. The means for the pain score and heart rate of the topical lidocaine/prilocaine cream group were lower than those of the morphine group (P<0.01) and the Kolcaba comfort level was higher (P<0.01). Local dermal application of the compound lidocaine cream can be used as an alternative to the systemic morphine administration in cancer wound care for its safety and effectiveness. In addition, it can improve the patients' comfort and quality of life.

Eutectic mixture of lidocaine and prilocaine versus 1% lidocaine injection for lumbar punctures in pediatric oncology patients.

BACKGROUND: The role of local analgesics for lumbar punctures (LPs) in pediatric oncology patients has not been specifically studied. AIM: To compare the efficacy of eutectic mixture of local anesthetics (EMLA) cream to 1% lidocaine injection for LPs. METHOD: This was a retrospective observational study of all patients receiving either EMLA cream (EMLA group) or 1% lidocaine subcutaneous injection (lidocaine group) in addition to fentanyl and propofol for LPs over 18 months. Demographics, vital parameters, procedural and recovery times, propofol and fentanyl doses, and adverse events were studied. RESULTS: Two hundred ninety LPs in 49 children were studied: 148 in the EMLA group and 142 in the lidocaine group. There was no difference in demographics or preprocedural parameters between the two groups. LPs in the EMLA group were completed in a shorter time (7.5 minutes [CI 7.0-8.1] vs 9.4 minutes [CI 8.9-9.9]) with a faster recovery time (38.7 minutes [CI 36.9-40.9] vs 43.9 minutes. [CI 41.9-45.9]) as compared with the lidocaine group (P < 0.001). The EMLA group required less maintenance doses (0.54 mg/kg [CI 0.47-0.62] vs 1.14 mg/kg [CI 1.06-1.21]) and total doses (2.58 mg/kg [CI 2.42-2.75] vs 3.12 mg/kg [CI 2.95-3.29]) of propofol as compared with the lidocaine group (P < 0.0001). Adverse events in the EMLA group were less (19% vs 41%) as compared with the lidocaine group (P < 0.0001). CONCLUSION: The addition of EMLA cream for procedural sedation for LPs in pediatric oncology patients significantly improves pain management in comparison with 1% lidocaine injection.

Disminuyendo el dolor en los procedimientos invasivos durante la hospitalización pediátrica: ¿ficción, realidad o realidad virtual? / Reducing the pain in invasive procedures during paediatric hospital admissions: Fiction, reality or virtual reality?

Introducción: La realización de procedimientos invasivos dolorosos con fines terapéuticos o diagnósticos en pacientes pediátricos hospitalizados es frecuente en la práctica diaria. Se deben buscar estrategias encaminadas a disminuir el dolor y la ansiedad durante estas técnicas, como el uso de realidad virtual (RV). Materiales y métodos: Se realizó un estudio observacional, analítico y prospectivo, en el cual se incluyeron todos los pacientes pediátricos hospitalizados de entre 4 y 15 años que precisaron procedimientos invasivos. Se recogieron escalas de valoración de dolor y ansiedad a los pacientes (ajustadas a su edad), familiares y personal sanitario y se comparó el uso de la RV, de manera aislada y asociado a una crema anestésica (prilocaína/lidocaína crema 2,5%), con un grupo control en el que no se utilizó ninguna técnica analgésica. Resultados: Se incluyeron 58 pacientes, de los cuales 38 usaron la RV (grupo RV) y 20 pacientes no recibieron ninguna técnica analgésica ni de distracción (grupo control). El uso de RV disminuyó las puntuaciones en la mediana de las escalas de dolor en niños, familiares y personal sanitario (grupo control 4/5 vs. grupo RV 1/5, p < 0,001), y en las escalas de ansiedad en niños (grupo control 4/5 vs. grupo RV 1/5, p = 0,001). En el análisis multivariante, el número de punciones (R2: 0,5; β: 0,6; p = 0,01) y la ausencia de técnicas coadyuvantes (β: -0,9; p = 0,02) se asociaron con puntuaciones más elevadas en la escala del dolor en niños. Comentarios: El empleo de RV disminuy:e el dolor y la ansiedad durante la realización de procedimientos invasivos en pacientes pediátricos hospitalizados

Introduction: Potentially painful invasive procedures are often performed for diagnostic or therapeutic purposes in hospitalised paediatric patients. Approaches, such as virtual reality (VR), should be sought in order to minimise pain and anxiety during these procedures. Materials and methods: Hospitalised patients between 4 and 15-years-old requiring an invasive procedure were included. Pain and anxiety evaluation scales were given to children, relatives and health workers. A comparison was made with patients in whom VR was used (with or without concomitant use of a prilocaine/ lidocaine 2.5% analgesic cream) and patients in whom neither VR nor analgesic cream were used. Results: The study included 58 patients, 38 in the VR group and 20 in the control group. Pain scores, as performed by patients, relatives and health workers, significantly decreased in the VR group (control group median 4/5 vs. VR group median 1/5, P < .001). Patient-reported anxiety scales were also lower in the VR group (control group median 4/5 vs. VR group 1/5, P = .001). The number of punctures (R2: 0.5, β: 0.6; P = .01) and the lack of analgesic techniques (β: -0.9; P = .02) were associated with higher scores in patient-reported pain scales. Comments: The use of VR can reduce pain and anxiety during invasive procedures in hospitalized children

[Evaluation of protocols on the use of analgesics for pain management in patients with extracorporeal shock wave lithotripsy (ESWL)]. / Evaluation des protocoles analgésiques pour la prise en charge de la douleur au cours de la lithotripsie extra corporelle.

Extracorporeal shock wave lithotripsy-related pain is the largest limiting factor in this technique. Our study aimed to compare the effectiveness of different types of analgesics for pain management used during ESWL sessions. We conducted a prospective study of 300 patients with urinary lithiasis justifying ESWL treatment. The patients were randomized to three groups: group I, included 100 patients who received intramuscular injection of 2cc of physiological saline solution (placebo), group II included 100 patients who received intramuscular injection of ketoprofen 100mg while group III included 100 patients who received lidocaine and prilocaine topical cream. Visual Analog Scale (VAS) was used to assess pain 10 minutes after and at the end of the session. Mean VAS score 10 minutes after and at the end of ESWL session was 3.7 and 4.91 respectively. There was no significant difference among the three groups with respect to: epidemiological data (age, sex, BMI, patient's history) and the characteristics of the renal stone (side, size, location, presence or not of double-J ureteral catheter). Eleven patients in the Group I terminated treatment early, with a significant difference compared to the other groups (p=0.003). VAS score 10 minutes after and at the end of ESWL session was statistically higher in Group I compared to Groups II and III (p < 0.001). Moreover, ESWL session was significantly more effective in Groups (II and III) compared to Group I (p<0.001). Pain treatment is necessary during ESWL sessions. Two painkillers molecules were assessed, which showed good pain control as well as an increase in the effectiveness of lithotripsy.

The effects of lidocaine-prilocaine cream on responses to intravenous catheter placement in cats sedated with dexmedetomidine and either methadone or nalbuphine.

OBJECTIVE: To compare the reaction to cephalic intravenous (IV) catheter placement with or without lidocaine-prilocaine cream in cats sedated with dexmedetomidine and methadone or nalbuphine. STUDY DESIGN: Prospective, randomized, blind study. ANIMALS: A group of 24 female mixed breed cats. METHODS: Cats were randomly allocated to one of the two sedation protocols: dexmedetomidine (0.01 mg kg-1) and methadone (0.3 mg kg-1; DEXMET) or dexmedetomidine (0.01 mg kg-1) and nalbuphine (0.3 mg kg-1; DEXNALB). Sedation was scored 30 minutes later using a visual analog scale. Subsequently, a 2 × 3.5 cm area of the antebrachium over the cephalic vein was clipped, and half the cats within each protocol were randomly assigned for topical lidocaine-prilocaine cream (treatment), whereas no cream was applied to other cats (control). After 20 minutes, an attempt was made to place a 24 gauge catheter into the cephalic vein and the reaction of the cats to this procedure was scored using a numeric scale 0-3. Sedation and catheterization reaction scores were compared between sedation protocols and whether cats were administered lidocaine-prilocaine cream or not using the Friedman test followed by the Bonferroni procedure. A p value < 0.05 was considered significant. RESULTS: Sedation scores were not different between sedation protocols or between treatment and control cats within each protocol. All cats administered lidocaine-prilocaine cream showed no reaction to IV catheter placement. Among the control cats, no response was observed in one cat in DEXNALB. Catheterization reaction score was lower in the treatment cats in both the sedation protocols when compared with their respective controls. CONCLUSIONS AND CLINICAL RELEVANCE: Lidocaine-prilocaine cream applied for 20 minutes abolished the reaction to catheterization in cats sedated with dexmedetomidine and nalbuphine or methadone. Facilitation of IV catheter placement occurred within 20 minutes of lidocaine-prilocaine application.

Analgesia for lumbar puncture in infants and children.

Question As a family physician who works in the local community emergency department, my skills include performing lumbar puncture in young children and infants. I hear conflicting recommendations in regard to provision of analgesia during lumbar puncture in these patients. Does local analgesia affect the success rate of the procedure? What is the best practice for analgesia in young children and infants?Answer Lumbar puncture is one of the most commonly encountered painful procedures in pediatric medicine; it is imperative for timely diagnosis of central nervous system infections in febrile young infants. For many years it has been documented that health care providers provide suboptimal analgesia, despite the understanding that this is a painful procedure for infants and children of all ages. Using a lidocaine and prilocaine combination or a 1% lidocaine infiltration (or both) is recommended and has been associated with improved outcomes during the procedure.

Randomized, double-blind, phase III clinical study of a novel nanotechnological topical anesthetic formulation containing lidocaine 25 mg/g and prilocaine 25 mg/g (nanorap) in skin phototypes I-III patients with ablative fractional CO2 laser treatment indication in the forehead.

BACKGROUND AND OBJECTIVES: Nanotechnology may increase the speed of penetration into the skin. This study evaluated the efficacy, safety, and pharmacokinetics of a novel topical anesthetic nanocapsule formulation (2 g) containing 2.5% lidocaine and 2.5% prilocaine (nanorap-test formulation) compared to placebo (control formulation) in skin types I-III patients of both sexes submitted to the ablative fractional CO2 laser treatment. METHODS: The patients (n = 120) included in this double-blind, single-center, randomized trial, received topical application of 2 g of the test formulation (50 mg lidocaine + 50 mg prilocaine) and placebo on the forehead region. Efficacy was assessed as pain sensation in four quadrants of each side of the forehead using a visual analogue scale immediately (0 min) and at 30, 60, and 90 minutes after laser application compared to placebo. The safety and tolerability of the test product were evaluated based on the occurrence of systemic adverse events as well as the occurrence of immediate and late skin reactions. Pharmacokinetic evaluation was performed in plasma of eight patients using a validated LC-MS/MS method for drugs quantification. RESULTS: Nanorap induced a clinically significant reduction in the pain assessment at all evaluated times (57.2%, 41.6%, 38.6%, and 37.3% at 0, 30, 60, and 90 minutes after drug application, respectively. Mean values of Cmax were 14.20 and 5.36 ng/ml and tmax were 3.5 and 1.8 hour for lidocaine and prilocaine, respectively. No systemic adverse events were observed. CONCLUSION: The nanorap formulation demonstrated a clinically and statistically significant efficacy providing analgesia after the ablative fractional CO2 laser therapy in the investigated patients, when compared to placebo. The product also presented good safety and tolerability. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Interventions for intra-operative pain relief during postpartum mini-laparotomy tubal ligation.

BACKGROUND: Postpartum mini-laparotomy tubal ligation (PPTL) is a contraceptive method that works by interrupting the patency of the fallopian tubes. Several methods are used for intraoperative pain relief, such as systemic administration of opioids or intraperitoneal instillation of lidocaine. OBJECTIVES: To evaluate the effectiveness of and adverse effects associated with interventions for pain relief in women undergoing PPTL. SEARCH METHODS: We searched for eligible studies published on or before 31 July 2017 in the CENTRAL Register of Studies Online, MEDLINE, Embase, PsycINFO, and CINAHL. We examined review articles and searched registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We included randomised controlled trials (RCT) that compared perioperative pain relief measures during PPTL. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the titles, abstracts, and full-text articles of potentially relevant studies for inclusion. We extracted the data from the included studies, assessed risk of bias, and calculated and compared results. Discrepancies were resolved by discussion, or by consulting a third review author. We computed the inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes, and the mean difference (MD) with 95% CI for continuous variables. MAIN RESULTS: We found only three RCTs, in which a total of 230 postpartum women participated. Most of our analyses were based on relatively small numbers of patients and studies. Overall, the certainty of evidence regarding the effectiveness of interventions was low, due to risk of bias and imprecision. We found very low-certainty evidence regarding the safety of interventions because of risk of bias and imprecision. Two studies had unclear risk of selection bias. One study had unclear risk of reporting bias and a high risk of other bias associated with the study protocol.Women who received an intraperitoneal instillation of lidocaine experienced lower intensity intraperitoneal pain than those given a placebo (pooled MD -3.34, 95% CI -4.19 to -2.49, three studies, 190 participants, low-certainty evidence), or an intramuscular injection of morphine (MD -4.8, 95% CI -6.43 to -3.17, one study, 40 participants, low-certainty evidence). We found no clear difference in intraperitoneal pain between women who had an intramuscular injection of morphine added to an intraperitoneal instillation of lidocaine and those who had an intraperitoneal instillation of lidocaine alone (MD -0.40, 95% CI -1.52 to 0.72, one study, 40 participants, low-certainty evidence). An intramuscular injection of morphine alone was not effective for intraperitoneal pain relief compared to placebo (MD 0.50, 95% CI -1.33 to 2.33, one study, 40 women, low-certainty evidence). None of the studies reported any serious adverse events but the evidence was very low-certainty. Intraperitoneal instillation of lidocaine may reduce the number of women requiring additional pain control when compared to placebo (RR 0.27, 95% CI 0.17 to 0.44, three studies, 190 women, low-certainty evidence). AUTHORS' CONCLUSIONS: An intraperitoneal instillation of lidocaine during postpartum mini-laparotomy tubal ligation before fallopian tubes were tied may offer better intraperitoneal pain control, although the evidence regarding adverse effects is uncertain. We found no clear difference in intraperitoneal pain between women who received a combination of an injection of morphine, and intraperitoneal instillation of lidocaine and those who received an intraperitoneal instillation of lidocaine alone. These results must be interpreted with caution, since the evidence overall was low to very low-certainty.