Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

Phase 2 Completed 110 enrolled Mount Sinai Hospital, Canada Striving for Excellence Fund, Mount Sinai Hospital · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular injection in term neonates.

Timeline

Start: 2003-07
Primary completion: 2004-12
Completion: 2004-12

Outcome

Missed primary endpoint

paper During i.m. injection, the mean (SD) percent facial grimacing score was 70% (30%) for the amethocaine group compared with 75% (34%) for the placebo group (P = 0.41). PMID 18343253 ↗

paper Topical amethocaine gel 4% was ineffective in reducing pain on i.m. injection of vitamin K in these full-term neonates. PMID 18343253 ↗

Publications

Results Shah VS, Taddio A, Hancock R, Shah P, Ohlsson A. Topical amethocaine gel 4% for intramuscular injection in term neonates: a double-blind, placebo-controlled, randomized trial. Clin Ther. 2008 Jan;30(1):166-74. doi: 10.1016/j.clinthera.2008.01.018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	tetracaine	Other / unclassified	1 g	Topical

Indications

No indication recorded.