CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Eucerin plus +1 moredrug
Likely dose
Eucerin plus 1gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00267111
NCT00267111Phase 2Completed
CompareCT.gov

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

Mount Sinai Hospital, Canada·interventional·Posted Dec 20, 2005·Updated Jul 30, 2024

In Brief

A Phase 2 clinical trial evaluating Eucerin plus and Amethocaine gel 4% for Pain. Completed, enrolled 110 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesCanada
CollaboratorsStriving for Excellence Fund, Mount Sinai Hospital

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2005
Enrollment StartJul 1, 2003
Primary CompletionDec 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.5 years ago

Interventions

Eucerin plusdrug

1g, single application

Amethocaine gel 4%drug

1 g, single application