Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
Launched by MOUNT SINAI HOSPITAL, CANADA · Dec 19, 2005
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
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 ra...
Gender
ALL
Eligibility 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
About Mount Sinai Hospital, Canada
Mount Sinai Hospital, located in Canada, is a leading academic health institution renowned for its commitment to innovative research and high-quality patient care. As a sponsor of clinical trials, Mount Sinai Hospital leverages its extensive expertise in various medical disciplines to advance clinical knowledge and develop new therapies. The hospital collaborates with a diverse network of healthcare professionals, researchers, and institutions to conduct rigorous trials that aim to improve health outcomes and enhance the quality of life for patients. With a focus on ethical standards and patient safety, Mount Sinai Hospital is dedicated to translating scientific discoveries into effective clinical practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Patients applied
Trial Officials
Vibhuti S Shah, MD, FRCPC
Principal Investigator
MOUNT SINAI HOSPITAL
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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