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A Randomized Clinical Trial of Jet-Injected Lidocaine to Reduce Venipuncture Pain for Young Children.

ABSTRACT: The J-Tip (National Medical Products Inc, Irvine, CA) uses air instead of a needle to push lidocaine into the skin. To our knowledge, no studies have investigated its use for venipuncture in young children. We determine whether the J-Tip decreased venipuncture pain in young children compared with vapocoolant spray.Children aged 1 to 6 years were randomized into 3 groups: intervention (J-Tip), control (vapocoolant spray), and sham (vapocoolant spray and pop of an empty J-Tip). The procedure was videotaped and scored with the Face, Legs, Activity, Cry and Consolability (FLACC) tool at 3 points; baseline, before approach; device, at J-Tip deployment; and at venipuncture. The FLACC tool was scored 0 (none) to 10 (severe). Comparisons of pain scores over time were made with the generalized estimating equation. Venipuncture success and adverse effects were assessed and compared with ?(2).Two hundred five children enrolled: intervention 96, control 53, and sham 56. There were no between-group differences in baseline characteristics. There was no mean change in pain scores from device to venipuncture in the intervention group (0.26; 95% confidence interval [CI] -0.31 to 0.82), but there was an increase in pain in the control (2.82; 95% CI 1.91 to 3.74) and sham (1.68; 95% CI 0.83 to 2.52) groups. This change was greater for the control and sham compared to the intervention group. There was no difference in venipuncture success between groups. No severe adverse events occurred. Minor adverse events were the same between groups.Use of the J-Tip for children aged 1 to 6 years reduced venipuncture pain compared with vapocoolant spray or sham treatment.

SUBMITTER: Lunoe MM

PROVIDER: S-EPMC4863077 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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A Randomized Clinical Trial of Jet-Injected Lidocaine to Reduce Venipuncture Pain for Young Children.

Lunoe Maren M MM Drendel Amy L AL Levas Michael N MN Weisman Steven J SJ Dasgupta Mahua M Hoffmann Raymond G RG Brousseau David C DC

Annals of emergency medicine 20150429 5

<h4>Study objective</h4>The J-Tip (National Medical Products Inc, Irvine, CA) uses air instead of a needle to push lidocaine into the skin. To our knowledge, no studies have investigated its use for venipuncture in young children. We determine whether the J-Tip decreased venipuncture pain in young children compared with vapocoolant spray.<h4>Methods</h4>Children aged 1 to 6 years were randomized into 3 groups: intervention (J-Tip), control (vapocoolant spray), and sham (vapocoolant spray and pop ...[more]

PMID: 25935844

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Project description:Intravenous lidocaine, a potent local anesthetic with analgesic and anti-inflammatory properties, has been shown to be an effective adjunct that reduces intra- and postoperative opioid consumption and facilitates pain management in adults. While it shows promise for use in the pediatric population, limited evidence is available.ObjectivesTo determine if general anesthesia with intraoperative intravenous lidocaine infusion versus general anesthesia without intravenous lidocaine infusion in children undergoing laparoscopic appendectomy decreased opioid requirements intra- and postoperatively.DesignA single-center parallel single-masked randomized controlled study. A computer-generated blocked randomization list was used to allocate participants. The study was conducted between March 2019 and January 2020.SettingPediatric teaching hospital in Poland.ParticipantsSeventy-four patients aged between 18?months and 18?years undergoing laparoscopic appendectomy. Seventy-one patients fulfilled the study requirements.InterventionIntravenous lidocaine bolus of 1.5?mg/kg over 5?min before induction of anesthesia followed by lidocaine infusion at 1.5?mg/kg/h intraoperatively. The infusion was discontinued before the patients' transfer to the postanesthesia care unit (PACU).Primary outcome measureThe primary outcome measure was total nalbuphine requirement in milligrams during the first 24?h after surgery.Secondary outcome measuresThe secondary outcome measures were intraoperative fentanyl consumption, intraoperative sevoflurane consumption, time to the first rescue analgesic request, incidence of postoperative nausea and vomiting during the first 24?h after surgery, frequency of side effects of lidocaine.ResultsChildren (n?=?74) aged 5-17 randomly allocated to receive intraoperative lidocaine infusion (n?=?37) or no intervention (n?=?37). Seventy-one were included in the analysis (35 in the study group and 36 in the control group). There was no difference in the cumulative dose of nalbuphine in the first 24?h after removal of the endotracheal tube between groups [median of 0.1061 (IQR: 0.0962-0.2222) mg/kg in the lidocaine group, compared to the control group median of 0.1325 (IQR: 0.0899-0.22020) mg/kg, p?=?0.63]. Intraoperative fentanyl consumption was lower in the lidocaine group [median of 5.091 (IQR: 4.848-5.714) ?g/kg] than in the control group [median of 5.969 (IQR: 5.000-6.748), p?=?0.03]. Taking into account the additional doses administered based on clinical indications, the reduction in the requirement for fentanyl in the lidocaine group was even greater [median of 0.0 (IQR: 0.0-0.952) vs 0.99 (IQR: 0.0-1.809) ?g/kg, p?=?0.01]. No difference was observed in the sevoflurane consumption between the two groups [median of 32.5?ml (IQR 25.0-43.0) in the lidocaine group vs median of 35.0?ml (IQR: 23.5-46.0) in the control group, p?=?0.56]. The time to first analgesic request in the lidocaine group was prolonged [median of 55 (IQR: 40-110) min in the lidocaine group vs median of 40.5 (IQR: 28-65) min in the control group, p?=?0.05]. There was no difference in the frequency of PONV between the two groups (48.57% in the lidocaine group vs 61.11% in the control group, p?=?0.29). No lidocaine related incidence of anaphylaxis, systemic toxicity, circulatory disturbances or neurological impairment was reported, during anesthesia or postoperative period.ConclusionsIntraoperative systemic lidocaine administration reduced the intraoperative requirement for opioids in children undergoing laparoscopic appendectomy. This effect was time limited, and hence did not affect opioid consumption in the first 24?h following discontinuation of lidocaine infusion.Trial registrationNCT03886896 .

Project description:IntroductionIntravenous insertion (IVI) is a very common procedure in the emergency department (ED). IVI is often painful and stressful for both children and their families. Currently, distraction therapy is not used as a standard of care for IVI in North America. We propose that interaction with a humanoid robot may effectively distract children during IVI thereby reducing their pain and distress.Methods and analysisThis randomised controlled superiority trial will be conducted in a Canadian paediatric ED. We plan to recruit 80 patients. Children will be eligible if they (1) are 6 to 11 years of age, (2) need an IVI, (3) are fully conscious and alert, (4) have sufficient knowledge of the English language to understand and complete the study assessments and (5) are accompanied by a legal guardian. Our primary objective is to compare patient-reported pain and distress with the use of distraction (via a humanoid robot) versus standard care in children. The primary outcomes will be (1) self-reported pain, as measured by the Faces Pain Scale-Revised and (2) observed distress, as measured by the Observational Scale of Behavioural Distress-Revised. Secondary outcomes will include (1) measuring parental anxiety, (2) examining the association between parental anxiety and child outcomes and (3) children's degree of engagement with the humanoid robot via the Intrinsic Motivation Inventory tool. First enrolment occurred in April 2017 and is ongoing.Ethics and disseminationThis study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent to participate will be obtained from all participants' parents/guardian, in conjunction with assent from the participant themselves. This study data will be submitted for publication regardless of results. Purchase of the robot was facilitated through a Stollery Children's Hospital Foundation donation. Recruitment costs are supported by the Women and Children's Health Research Institute.Trial registration numberNCT02997631; Pre-results.

Project description:BackgroundSome children feel pain during wound closures using tissue adhesives. We sought to determine whether a topically applied analgesic solution of lidocaine-epinephrine-tetracaine would decrease pain during tissue adhesive repair.MethodsWe conducted a randomized, placebo-controlled, blinded trial involving 221 children between the ages of 3 months and 17 years. Patients were enrolled between March 2011 and January 2012 when presenting to a tertiary-care pediatric emergency department with lacerations requiring closure with tissue adhesive. Patients received either lidocaine-epinephrine-tetracaine or placebo before undergoing wound closure. Our primary outcome was the pain rating of adhesive application according to the colour Visual Analogue Scale and the Faces Pain Scale--Revised. Our secondary outcomes were physician ratings of difficulty of wound closure and wound hemostasis, in addition to their prediction as to which treatment the patient had received.ResultsChildren who received the analgesic before wound closure reported less pain (median 0.5, interquartile range [IQR] 0.25-1.50) than those who received placebo (median 1.00, IQR 0.38-2.50) as rated using the colour Visual Analogue Scale (p=0.01) and Faces Pain Scale--Revised (median 0.00, IQR 0.00-2.00, for analgesic v. median 2.00, IQR 0.00-4.00, for placebo, p<0.01). Patients who received the analgesic were significantly more likely to report having or to appear to have a pain-free procedure (relative risk [RR] of pain 0.54, 95% confidence interval [CI] 0.37-0.80). Complete hemostasis of the wound was also more common among patients who received lidocaine-epinephrine-tetracaine than among those who received placebo (78.2% v. 59.3%, p=0.008).InterpretationTreating minor lacerations with lidocaine-epinephrine-tetracaine before wound closure with tissue adhesive reduced ratings of pain and increased the proportion of pain-free repairs among children aged 3 months to 17 years. This low-risk intervention may benefit children with lacerations requiring tissue adhesives instead of sutures.Trial registrationClinicalTrials.gov, no. PR 6138378804.

Project description:BackgroundObesity increases the risk of opioid-related morbidity. Lidocaine patches have been shown to reduce postoperative pain after noncesarean surgeries.ObjectiveThis study aimed to determine whether the application of lidocaine patches around the cesarean incision in women with obesity reduces the total dose of opioids administered in the first 24 hours after cesarean delivery.Study designThis was a pilot single-blind randomized controlled trial of 61 women with obesity undergoing cesarean delivery at a community tertiary referral hospital staffed by academic physicians. After cesarean delivery, the allocated patches (either 5% lidocaine patches or placebo patches) were applied superior and lateral to the incision dressing and remained in place for 12 hours. The average cumulative opioid dose received within the first 24 hours after cesarean delivery was measured in morphine milligram equivalents. We also assessed pain and patient satisfaction. A sample size of 60 (30 per group) was determined to be adequate to inform a future appropriately powered randomized controlled trial. The primary outcome of morphine milligram equivalents was compared using the Student t test, and pain scores were compared using the Wilcoxon rank sum test.ResultsOf the 146 women screened between February 2019 and September 2019, 61 consented and were analyzed: 30 women were allocated to lidocaine patch and 31 were allocated to placebo (hydrocolloid patch). Women who were allocated to the lidocaine patch used an average of 87.0 (standard deviation, 35.8) morphine milligram equivalents of opioids in the first 24 hours compared with an average of 83.9 (standard deviation, 27.5) morphine milligram equivalents among women who were allocated to the placebo patch (P=.702). Women who were allocated to the lidocaine vs placebo patches reported median pain scores of 3.0 (interquartile range, 2.1-4.9) and 3.5 (interquartile range, 2.5-5.0), respectively (P=.217). The time to the first dose of opioids, total number of opioid doses, and total morphine milligram equivalents in 48 hours and for the entire hospital stay did not differ. Patient satisfaction with both patches was high and not statistically different.ConclusionThis pilot suggests that 5% lidocaine patches applied superior and lateral to the cesarean incision are not effective at reducing the average total dose of morphine milligram equivalents administered in the first 24 hours after cesarean delivery among women with obesity, and they did not seem to improve median pain scores. An appropriately powered randomized trial would not be expected to demonstrate reduction in opioid use or pain.

Dataset Information

A Randomized Clinical Trial of Jet-Injected Lidocaine to Reduce Venipuncture Pain for Young Children.

Publications

A Randomized Clinical Trial of Jet-Injected Lidocaine to Reduce Venipuncture Pain for Young Children.

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