Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Collaborator: Striving for Excellence Fund, Mount Sinai Hospital
• Treatments: Tetracaine

Criteria

Inclusion Criteria:

1. Term neonates > 37 weeks and

2. Birth weight > 2500 grams (appropriate for gestational age - AGA) -

Exclusion Criteria:

1.Neonates with major congenital anomalies 2.Neonates with known neurological abnormalities (antenatally diagnosed) 3.Neonates who require admission to the neonatal intensive care unit at birth

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