Comparing two methods of topical anesthesia used before intravenous cannulation in pediatric patients.

INTRODUCTION: The purpose of this study was to compare the efficacy of two methods of topical anesthesia before venipuncture or intravenous cannulation of pediatric patients to assess which type of topical anesthetic would better alleviate pain in the least amount of time with the greatest success rate of cannulation. METHODS: This study was a randomly controlled trial of 100 preoperative pediatric patients aged 5 to 21 years. The following methods of topical anesthesia were compared: (a) iontophoresis of a topical solution of 2% lidocaine with epinephrine 1:100,000 using a Phoresor Dose Controller (PDC) with Numby Stuff electrodes and a eutectic mixture of local anesthetic and (b) 2.5% lidocaine and 2.5% prilocaine (eutectic mixture of local anesthetics [EMLA] cream). RESULTS: Children reported less pain with iontophoresis (M = 0.08) compared with EMLA cream (M = 1.88, P < .001). Time to accomplish topical anesthesia was shorter with iontophoresis (13 minutes) compared with EMLA cream (60 minutes, P < .001). Failure to accomplish venipuncture occurred 5 times with the iontophoresis method and 8 times with the EMLA method (not significant). No dermal burns resulted from use of iontophoresis. DISCUSSION: We conclude that use of iontophoresis in pediatric patients is safe, rapid, and significantly more effective than is EMLA cream in reducing pain associated with venipuncture or intravenous cannulation.     

CNS toxicity after topical application of EMLA cream on a toddler with molluscum contagiosum

EMLA (eutectic mixture of local anesthetics) cream is used topically to provide local anesthesia for a variety of painful superficial procedures. Although the side effects of EMLA are usually mild and transient local skin reactions, potential life threatening complications can be encountered. We report a case of central nervous toxicity after EMLA application for curettage of molluscum contagiosum lesions in a pediatric patient. This complication was the result of a therapeutic misadventure that led to an excessive application of EMLA cream over an extensive area causing an overdose of lidocaine and prilocaine with their subsequent systemic toxicities.     

Topical skin anesthesia for venous, subcutaneous drug reservoir and lumbar punctures in children

A new topical anesthetic ointment (EMLA, "eutectic mixture of prilocaine and lidocaine was studied in a double-blind, placebo-controlled trial to evaluate its efficiency in alleviating pain associated with venous, subcutaneous drug reservoir and lumbar punctures in children. Pain intensity was scored by the children themselves, using a visual analogue scale in which 0 corresponded to absence of sensation and 10 to the worst imaginable painful sensation. Venipunctures were performed on 18 children (6.1 to 12.2 years of age) equally divided in the study and control groups; EMLA cream was associated with lesser pain scores than those with placebo (means +/- SD: 2.8 +/- 2.4 vs 6.8 +/- 2.1, P less than .01). A crossover trial was used in the studies of subcutaneous drug reservoir and lumbar punctures, eight children (6.1 to 15.1 years of age) were tested for subcutaneous drug reservoir punctures; pain induced by this procedure was rated at 3.9 +/- 2.2 with placebo compared with 1.2 +/- 1.8 with EMLA cream (P less than .04). In lumbar punctures (14 children studied, 5.5 to 15.3 years of age), EMLA cream was again associated with less pain (1.9 +/- 1.9) than was placebo (5.6 +/- 3.0, P less than .01). It was concluded that the use of EMLA cream substantially reduces pain caused by venous, subcutaneous drug reservoir, and lumbar punctures in children and may therefore be offered to young patients, particularly those repeatedly submitted to such procedures.     

Pain perception and effectiveness of the eutectic mixture of local anesthetics in children undergoing venipuncture.

The emulsion of lidocaine and prilocaine (EMLA) is effective in preventing the pain of venipuncture in children. It is therefore important to identify children who could benefit the most from EMLA. We studied the safety and feasibility of two methods of application of EMLA (patch and cream) in a randomized, open-label trial of EMLA patch versus EMLA cream in 160 children with chronic diseases undergoing venipuncture. EMLA patch or cream was applied 60 to 120 min before puncture. Pain was assessed by the children using a visual analogue score. Children also scored the pain of their last puncture and the pain of removing the tape. EMLA patch and cream had similar efficacy (visual analogue scores for the venipuncture were 8.5 +/- 16 and 9.5 +/- 17 out of 100, respectively). Side effects occurred in similar frequencies in the two groups. Adhesiveness of the patch was less effective than that of the cream with Tegaderm. Age was a major determinant of pain perception; younger children recalled more severe pain in their previous puncture. Children recently diagnosed had higher visual analogue scores than those with a long history of chronic disease. We concluded that EMLA patch and cream have a similar efficacy in children undergoing venipuncture. Young children recently diagnosed with chronic disease are most likely to benefit from EMLA.     

Can Indian classical instrumental music reduce pain felt during venepuncture?

Objective  Local anesthetic agent is not usually used to reduce pain experienced by children undergoing venepuncture. This study was undertaken to determine comparative efficacy of local anesthetic cream, Indian classical instrumental music and placebo, in reducing pain due to venepuncture in children. Methods  Children aged 5–12yr requiring venepuncture were enrolled in a prospective randomized clinical trial conducted at a tertiary care center. They were randomly assigned to 3 groups: local anesthetic (LA), music or placebo (control) group. Eutactic mixture of local anesthetic agents (EMLA) and Indian classical instrumental music (raaga-Todi) were used in the first 2 groups, respectively. Pain was assessed independently by parent, patient, investigator and an independent observer at the time of insertion of the cannula (0 min) and at 1- and 5 min after the insertion using a Visual Analog Scale (VAS). Kruskal- Wallis and Mann-Whitney U tests were used to assess the difference amongst the VAS scores. Results  Fifty subjects were enrolled in each group. Significantly higher VAS scores were noted in control (placebo) group by all the categories of observers (parent, patient, investigator, independent observer) at all time points. The VAS scores obtained in LA group were lowest at all time points. However, the difference between VAS scores in LA group were significantly lower than those in music group only at some time-points and with some categories of observers (parent: 1min; investigator: 0-, 1-, 5 min and independent observer: 5 min). Conclusion  Pain experienced during venepuncture can be significantly reduced by using EMLA or Indian classical instrumental music. The difference between VAS scores with LA and music is not always significant. Hence, the choice between EMLA and music could be dictated by logistical factors.     

Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants

AIM—To assess the safety and efficacy of EMLA cream (eutectic mixture of local anaesthetics) used to induce surface anaesthesia for venepuncture in healthy preterm infants.METHODS—Nineteen infants, median gestational age 31 weeks (range 26-33 weeks) were assessed in a randomised, double blind, placebo controlled, cross-over trial. Changes in physiological variables (heart rate, blood pressure, oxygen saturation) and behavioural responses (neonatal facial coding system score, crying time) before and after venepuncture with EMLA cream were compared with those obtained with a placebo cream to assess efficacy. Toxicity was assessed by comparing methaemoglobin concentrations at 1 hour and 8 hours after application.RESULTS—There was no significant difference in efficacy between EMLA and placebo creams in physiological and behavioural responses. There was no significant difference in methaemoglobin concentrations one hour after the cream had been applied. At eight hours, however, concentrations were significantly higher after EMLA than placebo (p=0.016). There was no evidence of clinical toxicity.CONCLUSION—This study does not support the routine use of EMLA for venepuncture in healthy preterm infants.     

A randomized trial of eutectic mixture of local anesthetics during lumbar puncture in newborns

OBJECTIVE: To determine the efficacy of a topical anesthetic cream, eutectic mixture of local anesthetics (EMLA), in alleviating pain associated with lumbar puncture in newborns. DESIGN: Randomized double-blind placebo-controlled trial. SETTING: Neonatal intensive care unit of a university teaching hospital.Patients Sixty consecutive newborns (gestational age, >or=34 weeks) undergoing diagnostic lumbar puncture.Intervention Topical application of 1 g of EMLA or placebo 60 to 90 minutes before lumbar puncture. MAIN OUTCOME MEASURES: Heart rate, transcutaneous oxygen saturation level, and total behavioral score recorded on a video camera and graded according to the Neonatal Facial Coding System. RESULTS: Compared with baseline, all newborns experienced pain as evidenced by increased heart rate, decreased oxygen saturation level, and total behavioral score (all within-groups differences were significant using repeated-measures analysis of variance; P<.001) during the procedure. Compared with placebo, EMLA significantly attenuated the pain response as shown by a lower mean +/- SE heart rate (per minute), particularly at needle insertion (EMLA: 159.3 +/- 2.3; placebo: 175.2 +/- 2.7; P<.001) and needle withdrawal (EMLA: 153.8 +/- 2.6; placebo: 167.3 +/- 2.5; P<.001), and a lower mean +/- SE total behavioral score, again at insertion (EMLA: 4.0 +/- 0.3; placebo: 5.0 +/- 0.0; P =.004) and withdrawal (EMLA: 1.8 +/- 0.3; placebo: 3.9 +/- 0.3; P<.001). There was no statistically significant difference between groups with regard to oxygen saturation level. CONCLUSIONS: Lumbar puncture in newborns produces pain responses. Eutectic mixture of local anesthetics is an efficacious agent for reducing the pain associated with needle insertion and withdrawal during lumbar puncture in newborns.     

Use of eutectic mixture of local anesthetics in children

The Eutectic Mixture of Local Anesthetics (EMLA) is a topical application, which has proved to be a useful medication for providing pain relief among children. It is an emulsion containing a 1 : 1 mixture of lidocaine and prilocaine. The high concentration of the uncharged anesthetic base in the microdroplets of the emulsion ensure effective skin penetration. In the pediatric population EMLA has been shown to be efficacious when it is used prior to venipuncture, cannulation, lumbar puncture, laser treatment of port wine stains, curettage of molluscum contagiosum or vaccination. For several of these indications, the efficacy has been documented by double blind controlled trials, that have used objective and quasi-objective scales for assessing pain relief. The dose of EMLA is between 0.5 to 1 gram, and the cream should be applied half to one hour prior to the procedure. Local side effects are very mild, and the only systemic side effect of importance is the risk of methemoglobinemia in young infants. The literature has conflicting reports about the safety of EMLA in neonates.     

Allergy skin testing after topical anesthesia

Immediate skin test reactions are the hallmark of atopic diseases. EMLA (eutectic mixture of local anesthetics) is a local anesthetic that reduces the pain and apprehension for skin testing. We studied EMLA effects on the skin prick test with allergen and histamine. Reactions were evaluated by means of wheal and flare crossed diameters, speed of reaction and local temperature changes. One hour occlusion dressing with EMLA significantly delayed the beginning of reaction with antigen (129%) and histamine (101%). It decreased wheal diameter (33% and 15%) as well as local temperature variation (55% and 80%) respectively with antigen and histamine. Local anesthesia with EMLA probably interferes with histamine action and reduces the immediate skin test reaction. Therefore, it should not be used to reduce the pain of allergy skin testing.     

Auf dem Weg zur schmerzarmen Kinderklinik

Avoiding or reducing the pain experienced by inpatient children and adolescents during medical procedures is an issue of growing importance. To what extent the daily clinical routine has changed is unclear. In order to ascertain this we developed a six-page questionnaire and sent it to 424?facilities in Germany, 49 in Austria and nine in German-speaking Switzerland that carry out neuropaediatric procedures. We also contacted so-called social paediatric centres in Germany. The enquiry period was from June 2008 to January 2009. The return rate was 54% (Germany 55%, Austria 40%, Switzerland 66%). We found clear differences in the handling of painful procedures between the different countries as well as between various facilities. While in Switzerland and Austria use of EMLA (eutectic mixture of local anesthetics) is routine for taking blood samples or venous catheter insertion, and in Austria also for lumbar puncture, only a quarter of all facilities in Germany use EMLA cream ??often?? or ??routinely?? for blood tests, whereby its use largely depends on the physician in charge, especially at university clinics. Nevertheless, German physicians appear to be unsatisfied with the current status of EMLA usage. In all, 60% of the doctors surveyed at university clinics would prefer to see more frequent use of EMLA cream for their patients. Three quarters of the responding clinics use local anaesthesia ??almost always?? or ??often?? for lumbar puncture. The ratio increases significantly if the clinic has guidelines for pain management in place. The recommended EMLA application time of 60?min is adhered to by less than one-fifth of German physicians.     

Does EMLA cream application interfere with the success of venipuncture or venous cannulation? A prospective multicenter observational study

Venipuncture and intravenous cannulation are the most common painful procedures performed on children. The most widely used topical anesthetic is eutectic mixture of local anesthetics (EMLA). EMLA use is associated with a transient cutaneous vasoconstriction which can make it difficult to identify veins. We assessed with a prospective, multicenter, observational study whether EMLA interferes with venipuncture and intravenous cannulation. The primary study outcome was a success at first attempt in the course of venipuncture or venous cannulation. The study enrolled 388 children; 255 of them received EMLA and 133 did not. Eighty-six percent of procedures were successful at the first attempt in the EMLA group and 76.7 % in the no EMLA group. Conclusion: In this study, EMLA use did not interfere with the success of venipuncture or venous cannulation in children.     

Oral sucrose compares favourably with lidocaine-prilocaine cream for pain relief during venepuncture in neonates

To compare the relative efficacy of oral sucrose versus EMLA cream for pain relief during venepuncture, 51 full-term newborns (38M, 13F; postnatal age <4 d) in a stable condition were randomly allocated to one of four treatment groups: placebo (2 ml spring water); 2 ml sucrose 24% w/v; 1 g lidocaine-prilocaine 5% cream (EMLA); or EMLA plus sucrose. Water or a single dose of sucrose solution was administered orally 2 min before venepuncture. EMLA cream was applied in the antecubital fossa 45-60 min before venepuncture and covered by a Tegaderm dressing. A pacifier was given before skin puncture, but it was not actively held or replaced during the procedure or observation periods. In total, 55 venepunctures were performed blindly, always for clinical reasons. As indicators of pain, the total crying time was recorded and heart rate, respiratory rate and arterial oxygen saturation were measured blindly at baseline, immediately post-venepuncture, and 2 and 4 min afterwards. The main effects observed were: (i) time spent crying decreased significantly in the sucrose alone (p = 0.001) and EMLA plus sucrose (p = 0.008) groups; (ii) the above treatments attenuated significantly (p < 0.05) the immediate heart rate response to pain; and (iii) the concomitant use of EMLA did not increase further the analgesic efficacy of sucrose. Conclusion: This study shows that a 24% oral sucrose solution compares favourably with EMLA cream as a safe and cheap analgesic procedure to decrease pain responses to venepuncture in newborns.     

Methaemoglobin formation after the use of EMLA cream in term neonates

EMLA cream 5% (a eutectic mixture of lidocaine and prilocaine) is a topical anaesthetic that has become widely used to minimize pain from venipuncture in children. It has not, however, been recommended in neonates owing to the potential risk of methaemoglobinaemia induced by prilocaine. The aim of this study was to establish the safety of 1 g EMLA cream 5% used on intact skin in term neonates. Forty-seven neonates, aged 0-3 months, with a postconceptual age of ≥37 weeks and a body weight between 2.8 and 5.7 kg, were included in a double-blind, randomized, placebo-controlled study. After baseline observations a total dose of 1.0 g EMLA/placebo was applied to two sites (0.5 g site⁻¹) for 60-70 min. Venous methaemoglobin (metHb) levels were determined in each patient at baseline and at three randomly assigned times, 0.5-18h after application. Following application of the cream, the mean metHb levels were 1.17% (range 0.50-2.53) in the EMLA group and 0.96% (range 0.50-1.53) in the placebo group. The metHb concentrations were significantly higher in the EMLA group in the intervals from 3.5 to 13 h after application than in the placebo group, but were well below potentially harmful levels. Based on these results, a 1-h application of 1 g EMLA cream is safe when used on the intact skin of term neonates below 3 months of age.     

Randomized controlled trial of topical EMLA and breastfeeding for reducing pain during wDPT vaccination

The primary objective was to evaluate the analgesic effect of a eutectic mixture of local anesthetics (EMLA) during whole cell DPT vaccination. The secondary objective was to evaluate if the analgesic effect of EMLA was synergistic to breastfeeding. A randomized, placebo-controlled trial was done to include infants of up to 3 months of age who came for their first DPT vaccination. The outcome variables were duration of cry, latency of onset of cry, and Modified Facial Coding Score. Thirty babies were enrolled in each of three groups. The groups did not differ significantly in baseline characteristics. Median (interquartile range) of duration of cry was least [34.6 (24.1–72.2)?s] in babies receiving EMLA cream with breastfeeding (EB group), followed by 94.2 (46.1–180)?s in babies receiving EMLA cream with oral distilled water (EW group), as compared to 180.0 (180–180)?s in babies receiving placebo cream with oral distilled water (PCW group) (p?<?0.05). Mean (SD) of latency of cry was significantly greater in EB group [2.4 (1.14)?s] and EW group [1.9 (0.62)?s] as compared to babies in PCW group [1.5 (0.47)?s] (p?<?0.05), but the difference between EB and EW groups was not significant. Modified Facial Coding Score was significantly lower in EB group as compared to the other groups (p?<?0.05). Conclusions: Topical EMLA is effective in reducing pain and has a synergistic effect in analgesia when combined with breastfeeding during vaccination in infants.     

Midazolam compared with ketamine for invasive procedures

The combination of ketamine and topical placebo cream was compared with the combination of midazolam and topical lidocaine-prilocaine cream (EMLA) in 13 children with leukaemia undergoing bone marrow punctures. This double-blind, randomized, crossover study showed that the children prefer midazolam and EMLA as sedation for invasive procedures and that some parents and the nursing staff have doubts because of the anxiety during the procedure and the physical restraint that often is necessary during midazolam and EMLA. Both methods cause several, more or less unpleasant, side effects.     

Comparison of EMLA cream versus placebo in children receiving distraction therapy for venepuncture

Eutectic mixture of local anaesthetics (EMLA) cream is used routinely as a local anaesthetic prior to venepuncture in children. Despite this, however, a significant proportion of children will still be distressed. Cognitive-behavioural interventions, such as distraction by breathing and blowing exercises, have been used and found to be helpful as alternative coping strategies. There is, however, a paucity of data regarding effectiveness. We have evaluated the efficacy of distraction therapy as a coping strategy before and during venepuncture, and in these children evaluated the need for EMLA using a prospective, randomized, double-blind, placebo-controlled clinical trial. Twentyeight children attending for venepuncture were recruited, median age 6 y (range 4-8 y), and randomly allocated to receive either EMLA or a placebo cream. All were given distraction therapy prior to and during the procedure by a play specialist. Venepuncture was carried out by one investigator. A modified paediatric pain assessment chart was used for objective pain score at the end of the procedure. After one exclusion, the treatment group (17 children) and the placebo group (10 children) were similar: median age of 6 and 7 y (range 4-8), median baseline and postprocedure heart rate and oxygen saturation. The median (interquartile range) for total pain score in the treatment group was 1 (0 to 4.5) and in the control group 1 (0 to 2.3). There was no significant difference in pain score between the two groups (Mann-Whitney test, p = 0.7). The 95% confidence interval for the difference in pain score was -1.0 to +3.0. Conclusions: The low pain score in both groups suggests the effectiveness of distraction therapy, although factors such as skill of the operator and previous experience of the patient group are of relevance. There was no significant difference in the pain score between the EMLA and placebo groups, suggesting that in this age group if carefully selected children receive distraction during venepuncture EMLA may not be necessary.     

Management of pain from heel lance with lidocaine-prilocaine (EMLA) cream: is it safe and efficacious in preterm infants?

Hospitalized preterm infants undergo multiple painful heel lances. A two-phase, randomized, controlled trial was undertaken to determine the safety and efficacy of lidocaine-prilocaine 5% cream (EMLA, Astra Pharmaceuticals, L.P, Westborough, MA) for relieving pain from heel lance. One hundred twenty infants were randomly assigned to receive 0.5 g of EMLA or placebo cream for 30 minutes (Phase 1) or 60 minutes (Phase 2) before a routine heel lance. Efficacy was assessed using the Premature Infant Pain Profile (PIPP). Safety was determined by methemoglobin concentration 8 hours after EMLA application and by clinical signs of methemoglobinemia. No significant differences existed on PIPP scores between EMLA and placebo groups in Phase 1 (p < .480) or Phase 2 (p < .831). No infant had any clinical signs of methemoglobinemia. The mean methemoglobin concentration was 1.19% (.47). Approximately 10% of infants had minor skin reactions, and approximately 20% of EMLA-treated infants had blanching at the application site. The authors conclude that EMLA is safe but not efficacious for relieving pain from heel lance in preterm infants.     

The Effects of Instrumental Touching on Infant Pain Perception and the Effects of Eutectic Mixture of Local Anesthetics (EMLA) on the Reduction of Pain

Background:

Premature infants, who have to spend the first week of their lives in neonatal intensive care units (NICUs), experience pain and stress in numerous cases, and they are exposed to many invasive interventions. The studies have shown that uncontrolled pain experienced during early life has negative and long-term side effects, such as distress, and such experiences negatively affect the development of the central nervous system

Objectives:

The purpose of the study was to examine the effects of touching on infant pain perception and the effects of eutectic mixture of local anesthetic (EMLA) on the reduction of pain.

Patients and Methods:

Data for the study were collected between March and August 2012 from the neonatal clinic of a university hospital located in eastern Turkey. The population of the study consisted of premature infants who were undergoing treatment, completed the first month and who were approved for Hepatitis B vaccine. The study consisted of two experimental groups and one control group. Information forms, intervention follow-up forms, and Premature Infant Pain Profile (PIPP) were used to collect the data. EMLA cream was applied on the vastus lateralis muscles of the first experimental group before the vaccination. The second experimental group was vaccinated by imitation (placebo), without a needle tip or medicine. Vaccination was carried out using instrumental touch in this group. A routine vaccination was applied in the control group.

Results:

Mean pain scores of the group to which EMLA was applied were lower in a statistically significant way (P < 0.05) compared to the pain scores of the other groups. Moreover, it was determined that even though invasive intervention was not applied to the newborns, the touching caused them to feel pain just as in the placebo group (P < 0.005).

Conclusions:

The results demonstrated that EMLA was an effective method for reducing pain in premature newborns, and the use of instrumental touch for invasive intervention stimulated the pain perception in the newborns.     

A randomized double-blind, placebo-controlled trial of the EMLA® patch for the reduction of pain associated with intramuscular injection in four to six-year-old children

The effectiveness of a eutectic mixture lidocaine-prilocaine topical anaesthetic cream (EMLA) patch compared with a placebo patch in the reduction of pain associated with intramuscular immunization was evaluated. As part of the study, 161 children (aged 4-6-y) undergoing routine diphtheria, pertussis, tetanus and polio (DPTP) immunization in five urban and five rural private office settings were randomly assigned to an EMLA patch (n = 83) or a placebo patch control group (n = 78). Pain measurements included: child's self-report on a Faces Pain Scale; facial action on the Child Facial Coding System; the Children's Hospital of Eastern Ontario Pain Scale and parent and technician ratings on a Visual Analogue Scale. Parents also rated their own and their child's immunization-related anxiety on a Visual Analogue Scale. The EMLA patch group had significantly less pain on all four pain measures compared with the placebo group. Of the children in the placebo group, 43% had clinically significant pain, compared with 17% of children in the EMLA patch group. No severe adverse symptoms occurred as a result of either EMLA or placebo patch application. CONCLUSION: The EMLA patch reduced immunization pain in 4 to 6-y-old children during needle injection.     

Comparison of a topical mixture of lidocaine and prilocaine (EMLA) versus 1% lidocaine infiltration on wound healing

We compared a eutectic mixture of lidocaine and prilocaine (EMLA, Astra Pharmaceuticals, Inc) with 1% lidocaine infiltration to determine the effect on wound healing in a prospective single blind study using the rat model. Thirty-six wounds were assessed. No clinical or histologic evidence of infection or necrosis was present in any wound. Five wounds (two in the lidocaine and three in the EMLA group, P = 1.0) demonstrated a widened scar owing to healing by secondary intention following suture disruption. There was no significant difference between groups in the degree of inflammation (P = 0.08). We conclude that EMLA does not affect wound healing adversely and is comparable to 1% lidocaine infiltration in the animal model. Further study to determine its anesthetic effect in laceration repair is presently being undertaken.