Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

Pain Clinical Trial

Official title: Local Anaesthesia [Topical Amethocaine Gel (Ametop)] for Intramuscular Injection in Term Neonates: A Randomized Controlled Trial.

Status Completed

Clinical Trial 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.

Clinical Trial Description

This randomized controlled trial will assess the efficacy of topical amethocaine gel (Ametop) compared with placebo (Eucerin plus) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Neonatal pain response between groups will be assessed using the Neonatal Facial Action Coding System (NFCS) which is currently the gold standard for infant pain assessment, latency to first cry and cry duration. Parents' (father) perception of infant's pain will be assessed using a visual analogue scale (VAS) when possible.

Neonates will be randomized to receive either amethocaine gel or identical appearing placebo administered locally at the injection site (the upper part of the neonate's thigh) using a pre-prepared syringe 30 minutes prior to the administration of vitamin K. The gel or placebo will be covered using a Saran wrap. Each neonate will be videotaped during the procedure. Parents (father) will be present during the procedure (observing) so that they (he) can assess their neonate's pain response using VAS. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

• NCT number: NCT00267111
• Study type: Interventional
• Source: Mount Sinai Hospital, Canada
• Status: Completed
• Phase: Phase 2
• Start date: July 2003
• Completion date: December 2004