Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

Mount Sinai Hospital, Canada

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Eucerin plus; Drug: Amethocaine gel 4%

Study type: Interventional

Funder types: Other

Identifiers

NCT00267111

01-0086-E

00267111 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 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 randomized to receive either amethocaine gel or identical appearing placebo administered locally at the injection site (the upper part of the neonate's thigh) using a pre-prepared syringe 30 minutes prior to the administration of vitamin K. The gel or placebo will be covered using a Saran wrap. Each neonate will be videotaped during the procedure. Parents (father) will be present during the procedure (observing) so that they (he) can assess their neonate's pain response using VAS.

Enrollment: 110 patients

Sex: All

Ages: 24 to 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Amethocaine gel 4% Group

Experimental group

Description:

1 g of topical amethocaine gel 4%

Treatment:

Drug: Amethocaine gel 4%

Placebo Group

Placebo Comparator group

Treatment:

Drug: Eucerin plus