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Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

NCT00267111 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-07-30

Study results available
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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.

Conditions

Interventions

DRUG

Eucerin plus

1g, single application

DRUG

Amethocaine gel 4%

1 g, single application

Sponsors & Collaborators

  • Striving for Excellence Fund, Mount Sinai Hospital

    collaborator UNKNOWN

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Vibhuti S Shah, MD, FRCPC · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00267111 on ClinicalTrials.gov