Status:
COMPLETED
Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Striving for Excellence Fund, Mount Sinai Hospital
Conditions:
Pain
Eligibility:
All Genders
24-72 years
Phase:
PHASE2
Brief 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 H...
Detailed 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 intramu...
Eligibility Criteria
Inclusion
- Term neonates \> 37 weeks and
- Birth weight \> 2500 grams (appropriate for gestational age - AGA) -
Exclusion
- Neonates with major congenital anomalies
- Neonates with known neurological abnormalities (antenatally diagnosed)
- Neonates who require admission to the neonatal intensive care unit at birth
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00267111
Start Date
July 1 2003
End Date
December 1 2004
Last Update
July 30 2024
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5