Safety and Efficacy of a Topical Anesthetic for Neonatal Circumcision

PEDIATRICS ◽  
1993 ◽  
Vol 92 (5) ◽  
pp. 710-714 ◽  
Author(s):  
Kathleen B. Weatherstone ◽  
Lynn B. Rasmussen ◽  
Allen Erenberg ◽  
Emily M. Jackson ◽  
Katherine S. Claflin ◽  
...  

Objective. Circumcision is a common neonatal surgical procedure routinely performed without the use of anesthesia. The purpose of this study was to evaluate the safety and efficacy of topical lidocaine cream as an anesthetic for circumcision. Methods. Thirty newborns were studied in a randomized, double-blind, placebo-controlled study; 15 received a topical 30% lidocaine cream and 15 received the cream base alone. Vital signs were recorded, and preoperative and postoperative serum β-endorphin and lidocaine concentrations were measured. A videotape of the newborn was used to score behavioral changes. Results. Comparisions of the vital signs precircumcision and postcircumcision showed no differences between the placebo and treatment groups, with the exception of mean systolic blood pressure, which significantly increased in the placebo-treated newborns (P < .05). Serum β-endorphin concentrations increased postoperatively in 11 of 15 subjects receiving placebo, but decreased or remained unchanged in 10 of 15 subjects receiving lidocaine (P = .03, Fisher's exact test). When stress-related behaviors in the precircumcision and post-circumcision periods were compared, the mean increase in their occurrence was greater in the placebo than in the treatment group. There was no significant absorption of lidocaine as measured in the serum. Conclusion. Topical application of a 30% lidocaine cream as used in this study may be a safe and efficacious anesthetic for circumcision.

2018 ◽  
Vol 21 (11) ◽  
pp. 1120-1128 ◽  
Author(s):  
Muhammed Majeed ◽  
Shaheen Majeed ◽  
Kalyanam Nagabhushanam ◽  
Sivakumar Arumugam ◽  
Anurag Pande ◽  
...  

EBioMedicine ◽  
2019 ◽  
Vol 40 ◽  
pp. 574-582 ◽  
Author(s):  
Ellie Hershberger ◽  
Susan Sloan ◽  
Kristin Narayan ◽  
Catherine A. Hay ◽  
Patrick Smith ◽  
...  

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Amy S. Paller ◽  
◽  
John Browning ◽  
Milos Nikolic ◽  
Christine Bodemer ◽  
...  

Abstract Background Epidermolysis bullosa (EB) is a rare genetic disorder that manifests as blistering and/or skin erosion. There is no approved treatment for EB; current standard of care consists of wound and pain management. SD-101 6% is a topical cream containing 6% allantoin that was developed for treating skin lesions in patients with EB. The aim of this phase 3, multicenter, randomized, double-blind, vehicle-controlled study was to assess the efficacy and safety of SD-101 6% cream versus vehicle (0% allantoin) on lesions in patients with EB. Methods Eligible patients were ≥1 month old, had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10–50 cm2 in size that was present for ≥21 days. Patients were randomly assigned to SD-101 6% cream or vehicle, which was applied topically once a day to the entire body for 3 months. Primary efficacy endpoints were time to complete target wound closure within 3 months and the proportion of patients who experienced complete target wound closure within 3 months. Post hoc subgroup analyses were conducted by patient age and in those with body surface area index of total body wound burden ≥5% at baseline. Results In total, 169 patients were enrolled and randomly assigned to SD-101 6% (n = 82) or vehicle (n = 87). Baseline demographics and disease characteristics were similar between treatment groups. There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733 [0.365, 1.474]; nominal P = 0.390). A positive trend toward faster wound closure with SD-101 6% versus vehicle was observed in patients aged 2 to <12 years and those with total body wound burden ≥5% at baseline. SD-101 6% cream was well tolerated. Conclusions SD-101 6% cream for treatment of EB-associated lesions was not more effective than vehicle in shortening the time to complete target wound closure or achieving complete target wound closure within 3 months. Trial registration ClinicalTrials.gov, NCT02384460; Date of trial registration, February 13, 2015; First participant enrolled, March 11, 2015.


2019 ◽  
Vol 43 (2) ◽  
pp. 470-479 ◽  
Author(s):  
Pasquale Fino ◽  
Marco Toscani ◽  
Francesca Romana Grippaudo ◽  
Nicola Giordan ◽  
Nicolò Scuderi

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