A Randomized Clinical Trial of Jet-Injected Lidocaine to Reduce Venipuncture Pain for Young Children.
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ABSTRACT:
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]
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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 .
| S-EPMC7784324 | biostudies-literature
Project description:Pediatric patients usually experience high levels of pain and distress due to venipuncture. This randomised study aimed to evaluate the effects of virtual reality-based preprocedural education in comparison with video-based education in terms of pain and distress experienced by children scheduled to undergo venipuncture. Ninety children aged 4-8 years who were scheduled to undergo venipuncture surgery were randomly assigned to either a video or virtual reality group. Children in the video group received preprocedural education on venipuncture via a video displayed on a tablet and those in the virtual reality group received the same education via a head-mounted virtual reality display unit. The educational content for the two groups was identical. An independent assessor blinded to the group assignment observed the children's behavior and determined their Children's Hospital of Eastern Ontario Pain Scale scores, parental satisfaction score, procedure-related outcomes, venipuncture time, number of repeated procedures and difficulty score for the procedure. The virtual reality group experienced less pain and distress, as indicated by their Children's Hospital of Eastern Ontario Pain Scale scores compared with the video group (5.0 [5.0-8.0] vs. 7.0 [5.0-9.0], P = 0.027). There were no significant intergroup differences in parental satisfaction scores or procedure-related outcomes. For pediatric patients scheduled to undergo venipuncture, preprocedural education via a head-mounted display for immersive virtual reality was more effective compared with video-based education via a tablet in terms of reducing pain and distress.
| S-EPMC11349209 | biostudies-literature
Project description:INTRODUCTION:Intravenous 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 ANALYSIS:This 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 DISSEMINATION:This 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 NUMBER:NCT02997631; Pre-results.
| S-EPMC6303653 | biostudies-literature
Project description:Post-operative airway symptoms can be troublesome to patients following an uneventful general anesthesia with endotracheal intubation. In this study, we compared the effectiveness of lubricating an endotracheal tube with betamethasone gel or lidocaine jelly with using an unlubricated tube in reducing the incidence and severity of postoperative sore throat, hoarseness and cough.This was a prospective, randomized, single-blind comparative study carried out among 120 ASA I and II patients aged 18-65 years undergoing elective surgery under general anesthesia with endotracheal intubation. Patients were randomly divided into three groups of 40 patients each. Endotracheal tube used for patients in group C was unlubricated, while that for group B and group L were lubricated up to 15 cm mark with 2.5 ml of 0.05% betamethasone gel or 2% lidocaine jelly respectively. Incidence and severity of postoperative sore throat, hoarseness and cough were observed at 1, 6 and 24 h following extubation.At 24 h following extubation, group B had the lowest incidence of postoperative sore throat among the three groups (group B: 12.5% vs group L: 37.5% vs group C: 25%; p = 0.036). Severity of postoperative sore throat at 24 h was less with betamethasone (score 0: 87.5%, 1: 10%) compared with lidocaine (score 0: 62.5%, 1: 37.5%) and control (score 0:75%, 1: 20%) (p = 0.006). Observations at other times and of other variables were comparable.Wide spread application of 0.05% betamethasone gel to lubricate the endotracheal tube significantly reduces the incidence and severity of sore throat at 24 h of extubation but not of hoarseness or cough.
| S-EPMC5540535 | biostudies-other
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.
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Project description:In this large, sham-controlled, randomized trial, we examined the efficacy of the combination of standard treatment and paraspinous lidocaine injection compared with standard therapy alone in subjects with chronic low back pain. There is little research-based evidence for the routine clinical use of paraspinous lidocaine injection for low back pain. A total of 378 subjects with nonspecific chronic low back pain were randomized to 3 groups: paraspinous lidocaine injection, analgesics, and exercises (group 1, LID-INJ); sham paraspinous lidocaine injection, analgesics, and exercises (group 2, SH-INJ); and analgesics and exercises (group 3, STD-TTR). A blinded rater assessed the study outcomes at 3 time points: baseline, after treatment, and after 3 months of follow-up. There were increased frequency of pain responses and better low back functional scores in the LID-INJ group compared with the SH-INJ and STD-TTR groups. These effects remained at the 3-month follow-up but differed between all 3 groups. There were significant changes in pain threshold immediately after treatment, supporting the effects of this intervention in reducing central sensitization. Paraspinous lidocaine injection therapy is not associated with a higher risk of adverse effects compared with conventional treatment and sham injection. Its effects on hyperalgesia might correlate with changes in central sensitization.NCT02387567.There are few data to support paraspinous lidocaine injection use in patients with nonspecific chronic low back pain. Our results show that this therapy when combined with standard therapy significantly increases the number of responders versus standard treatment alone. Its effects on hyperalgesia might correlate with a change in central sensitization.
| S-EPMC4910884 | biostudies-literature
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.
| S-EPMC9516415 | biostudies-literature
Project description:ObjectivePain and distress associated with intranasal midazolam administration can be decreased by administering lidocaine before intranasal midazolam (preadministered lidocaine) or combining lidocaine with midazolam in a single solution (coadministered lidocaine). We hypothesized coadministered lidocaine is non-inferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration.MethodsRandomized, outcome assessor-blinded, noninferiority trial. Children aged 6 months to 7 years undergoing laceration repair received intranasal midazolam with preadministered or coadministered lidocaine. Pain and distress were evaluated with the Observational Scale of Behavioral Distress-Revised (OSBD-R) (primary outcome; non-inferiority margin 1.8 units) and the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Faces, Legs, Activity, Cry, Consolability (FLACC) scales and cry duration (secondary outcomes). Secondary outcomes also included adverse events, clinician and caregiver satisfaction, and pain and distress associated with intranasal lidocaine administration.ResultsFifty-one patients were analyzed. Mean OSBD-R scores associated with intranasal midazolam administration were 6.4 (95% confidence interval [CI] 5, 7.8) and 7 (95% CI 5.2, 8.9) units for preadministered and coadministered lidocaine, respectively. The difference of 0.6 (95% CI -1.7, 2.8) units represented an inconclusive non-inferiority determination. CHEOPS and FLACC scores and cry duration were similar between groups. OSBD-R, CHEOPS, and FLACC scores and cry duration associated with intranasal lidocaine administration were 3.8, 9.9, and 6 units, and 56 seconds, respectively. Clinicians considered coadministered lidocaine easier to administer.ConclusionPain and distress associated with intranasal midazolam administration were similar when using coadministered or preadministered lidocaine, but our non-inferiority determination was inconclusive. Administration of intranasal lidocaine by itself was associated with a measurable degree of pain and distress.Keywords: intranasal, midazolam, anxiolysis, sedation, emergency department, emergency medicine, pain, distress, pediatric, lidocaine, laceration.
| S-EPMC7771777 | biostudies-literature
Project description:STUDY OBJECTIVE:We compare the efficacy and safety of intravenous lidocaine with that of hydromorphone for the treatment of acute abdominal pain in the emergency department (ED). METHODS:This was a randomized, double-blind, clinical trial conducted in 2 EDs in the Bronx, NY. Adults weighing 60 to 120 kg were randomized to receive 120 mg of intravenous lidocaine or 1 mg of intravenous hydromorphone. Thirty minutes after administration of the first dose of the study drug, participants were asked whether they needed a second dose of the investigational medication to which they were randomized. Patients were also stratified according to clinical suspicion of nephrolithiasis. The primary outcome was improvement in pain scores of 0 to 10 between baseline and 90 minutes. An important secondary outcome was need for "off-protocol" parenteral analgesics, including opioids and nonsteroidal anti-inflammatory drugs. RESULTS:We enrolled 154 patients, of whom 77 received lidocaine and 77 received hydromorphone. By 90 minutes, patients randomized to lidocaine improved by a mean of 3.8 points on the 0-to-10 scale, whereas those randomized to hydromorphone improved by a mean of 5.0 points (mean difference 1.2; 95% confidence interval 0.3 to 2.2). Need for off-protocol "rescue" analgesics occurred for 39 of 77 lidocaine patients (51%) and 20 of 77 hydromorphone patients (26%) (difference 25%; 95% confidence interval 10% to 40%). Adverse events were comparable between groups. Among the subset of 22 patients with nephrolithiasis, lidocaine patients reported a mean improvement of 3.4 points on the pain scale, whereas hydromorphone patients reported a mean improvement of 6.4 points (mean difference 3.0; 95% confidence interval 0.5 to 5.5). CONCLUSION:Intravenous hydromorphone was superior to intravenous lidocaine both for general abdominal pain and a subset of patients with nephrolithiasis. A majority of patients randomly allocated to lidocaine required additional analgesics.
| S-EPMC6764530 | biostudies-literature
Project description:BackgroundVirtual reality (VR) has shown promise in reducing children's pain and anxiety during venipuncture, but studies on VR lack objective observations of pediatric coping. Notably, the process of capturing objective behavioral coping data can be labor- and personnel-intensive.ObjectiveThe primary aims of this pilot trial were to assess the feasibility of conducting a trial of VR in a pediatric emergency department and the feasibility of documenting observed coping behaviors during pediatric procedures. Secondarily, this study examined whether VR affects child and caregiver coping and distress during venipuncture in the pediatric emergency department.MethodsThis stratified, randomized, controlled pilot trial compared coping and distress between child life-supported VR engagement and child life specialist support without VR during painful procedures in children aged 7-22 years in the pediatric emergency department. An external control (reference group) received no standardized support. Primary feasibility outcomes included rates of recruitment, rates of withdrawal from VR, and rates of completed Child Adult Medical Procedure Interaction Scale-Short Form (CAMPIS-SF) observations. Secondary clinical outcomes were applied to venipuncture procedures and included CAMPIS-SF coping and distress (range 0-1.0), pain and anxiety on a visual analog scale (range 0-10), and cybersickness symptoms.ResultsOverall recruitment was 93% (66/71), VR withdrawal rate was 27% (4/15), and of the completed procedures, 100% (63/63) CAMPIS-SF observations were completed. A total of 55 patients undergoing venipuncture in the pediatric emergency department were included in the analyses of clinical outcomes: 15 patients (15 caregivers) randomized to VR, 20 patients (15 caregivers) randomized to child life specialist support, and 20 patients (17 caregivers) in the reference group. Patient coping differed across groups with higher coping in the VR group and child life specialist group than in the reference group (P=.046). There were no significant differences in the distress and pain ratings for patients and caregivers between the groups. Caregivers rated the lowest perceived anxiety in the child life specialist group (P=.03). There was no apparent change in cybersickness symptoms before and after VR use (P=.37).ConclusionsReal-time documentation of observed behaviors in patients and caregivers was feasible during medical procedures in which VR was utilized, particularly with the availability of research staff. VR and child life specialists improved coping in children during venipuncture procedures. Given the high participation rate, future studies to evaluate the efficacy of VR are recommended to determine whether an off-the-shelf VR headset can be a low-cost and low-risk tool to improve children's coping during venipuncture or other related procedures.Trial registrationClinicalTrials.gov NCT03686176; https://clinicaltrials.gov/ct2/show/NCT03686176.
| S-EPMC8367183 | biostudies-literature