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

Cruickshank, Amy; Qeadan, Fares; Kuttesch, John F.; Agarwal, Hemant

doi:10.1002/pbc.27957

Cited by 4 publications

(5 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Two reviewers agreed that 6 noninterventional publications met the criteria (Figure). A review of completed pragmatic trials for pediatrics in the ClinicalTrials.gov database from 2017 to 2019 did not identify any clinical trials that reported primarily relying on clinical RWD in the assessment of drug effectiveness. In examining common practices to control for bias in observational studies, we found that half of the 6 publications controlled for confounding by statistical analysis (Table), and none of the publications used propensity score matching.…”

Section: Resultsmentioning

confidence: 99%

Summary of Literature on Pediatric Real-world Evidence and Effectiveness

et al. 2021

View full text Add to dashboard Cite

The US Food and Drug Administration (FDA) has long used clinical real-world data (RWD) and clinical real-world evidence (RWE) to supplement information from traditional randomized clinical trials on the safety of medications in children and adults, but RWD and RWE are not commonly used to demonstrate effectiveness, especially in pediatrics. With the widespread use of electronic health care data, there may be new opportunities for RWE to assess the effectiveness of medical products that are on the market. The 21st Century Cures Act of 2016 provides specific milestones for the FDA to achieve in evaluating potential uses of clinical RWE to support regulatory decision-making. As part of that effort, the FDA published its Framework for FDA's Real-World Evidence Program in 2018 (https://www.fda.gov/media/ 120060/download). The initial question within the domain of clinical pediatric RWE is: what are the descriptive characteristics of existing clinical pediatric RWE effectiveness studies? This review of clinical pediatric RWE studies assessed studies from ClinicalTrials.gov and other published drug studies that focused on therapeutic effectiveness from 5 subspecialties (ie, psychiatry, cardiology, rheumatology, pulmonology, and oncology), which, based in part on analogous adult studies, could have promising clinical RWE application and could differ from one another in their approach to using clinical RWE to evaluate effectiveness.Methods | This cross-sectional study used Embase and PubMed to search articles in the 5 subspecialties that were published between January 1, 2017, and December 31, 2019 (Figure). We screened all articles by title and abstract. Publications were selected if more than 50% of the participants were children and the study had at least 2 arms. Since the data used in this study were publicly available and the study was deemed not human subjects research, this article did not require institutional review board approval or informed consent.

show abstract

Section: Resultsmentioning

confidence: 99%

Summary of Literature on Pediatric Real-world Evidence and Effectiveness

et al. 2021

View full text Add to dashboard Cite

show abstract

“…This study adds to prior reports demonstrating the safety and efficacy of EMLA cream in pediatric oncology patients undergoing sedation for LP. [9][10][11][12] Our study is notable for its design (prospective, randomized, double blind, and placebo-controlled), relatively large number of events (152), and multiple outcomes assessed (including propofol movement, complications, and satisfaction). Participants randomized to EMLA cream were less likely to move at the time of skin puncture, and were exposed to significantly lower doses of propofol.…”

Section: Discussionmentioning

confidence: 99%

“…7,8 Eutectic mixture of lidocaine (2.5%) and prilocaine (2.5%) (EMLA) cream is an Food and Drug Administration-approved local anesthetic indicated for numbing skin before injections and other medical procedures. Several studies have documented the safety and efficacy of EMLA cream for LPs in pediatric oncology patients, [9][10][11] including one which demonstrated that its use allowed for decreased doses of propofol. 12 The study by Whitlow et al 12 was published during our study period and demonstrated less propofol use in a crossover double blind population of 25 patients who each had two procedures.…”

mentioning

confidence: 99%

Eutectic Mixture of Lidocaine and Prilocaine Decreases Movement and Propofol Requirements for Pediatric Lumbar Puncture During Deep Sedation: A Randomized, Placebo-Controlled, Double Blind Trial

Hammon¹,

Pearsall

Smith

et al. 2021

Journal of Pediatric Hematology/Oncology

View full text Add to dashboard Cite

Deep sedation/general anesthesia is commonly used in pediatric oncology patients undergoing lumbar puncture (LP). Propofol is often used for sedation, with or without a narcotic. We hypothesized that eutectic mixture of lidocaine and prilocaine (EMLA) would allow for lower cumulative doses of propofol and less movement. We performed a prospective, randomized, double blind, placebo-controlled trial in children undergoing sedation for LP. Standard initial weight-based doses of propofol and fentanyl were administered, with either EMLA cream or a placebo cream applied topically. The primary outcome was the total dose of propofol administered to each patient. We also tracked patient movement and complications. Twenty-seven patients underwent 152 LPs. Patients randomized to EMLA cream (n = 75) were significantly more likely to receive a lower dose of propofol (2.94 mg/kg, SE = 0.25, vs. 3.22 mg/kg, SE = 0.19; P = 0.036) and to not require additional propofol doses (probability 0.49, SE = 0.08 vs. 0.69, SE = 0.06; P = 0.001) compared with patients randomized to placebo cream (n = 77). In addition, patients with EMLA cream were significantly less likely to demonstrate minor or major movement. EMLA cream results in less movement and less propofol administration in pediatric oncology patients undergoing sedation for LP.

show abstract

“…One of the few lidocaine injection-to-EMLA cream comparisons in the literature, a retrospective observational study, reported that EMLA cream shortened LP procedure time, required decreased Propofol, and resulted in fewer adverse events; however, the authors did not examine self-reported pain or nonimmediate outcomes. 9 Assessing self-reported pain is critical when examining pain management strategies as pain is an internal and subjective experience.…”

Section: Introductionmentioning

confidence: 99%

Comparison of EMLA Cream versus Lidocaine Injection for Lumbar Puncture Pain Control in Pediatric Oncology Patients

et al. 2022

View full text Add to dashboard Cite

Background Subcutaneous lidocaine injection and topical EMLA cream are both used to control lumbar puncture (LP) pain; however, local analgesia usage is not standardized. Methods We conducted a prospective, single-blinded, randomized-controlled crossover trial comparing the two modalities in reducing LP pain. Pediatric patients requiring serial LPs were randomly assigned to receive EMLA cream or lidocaine injection prior to LP. On the subsequent LP, analgesia was defaulted to the other agent. Pain was assessed using the Wong-Baker FACES Pain Rating Scale pre-procedure: 30 to 60 minutes post-LP, and 24 hours post-procedure. Results Ten patients were included in the analysis (median age: 5.5 years). Pain ratings at 1 and 24 hours post-LP did not differ between the two strategies (p = 0.79). No adverse local reactions were reported for either agent. Conclusion Accordingly, both lidocaine and EMLA cream provided effective LP pain control.

show abstract

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

Cited by 4 publications

References 35 publications

Summary of Literature on Pediatric Real-world Evidence and Effectiveness

Summary of Literature on Pediatric Real-world Evidence and Effectiveness

Eutectic Mixture of Lidocaine and Prilocaine Decreases Movement and Propofol Requirements for Pediatric Lumbar Puncture During Deep Sedation: A Randomized, Placebo-Controlled, Double Blind Trial

Comparison of EMLA Cream versus Lidocaine Injection for Lumbar Puncture Pain Control in Pediatric Oncology Patients

Contact Info

Product

Resources

About