Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

NCT ID: NCT00267111

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2004-12-31

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 Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular injection in term neonates.

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 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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Amethocaine gel 4% Group

1 g of topical amethocaine gel 4%

Group Type: EXPERIMENTAL

Amethocaine gel 4%

Intervention Type: DRUG

1 g, single application

Placebo Group

Group Type: PLACEBO_COMPARATOR

Eucerin plus

Intervention Type: DRUG

1g, single application

Interventions

Eucerin plus

1g, single application

Intervention Type: DRUG

Amethocaine gel 4%

1 g, single application

Intervention Type: DRUG

Other Intervention Names

Ametop

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

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Striving for Excellence Fund, Mount Sinai Hospital

UNKNOWN

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Vibhuti Shah

Staff Neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vibhuti S Shah, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Shah VS, Taddio A, Hancock R, Shah P, Ohlsson A. Topical amethocaine gel 4% for intramuscular injection in term neonates: a double-blind, placebo-controlled, randomized trial. Clin Ther. 2008 Jan;30(1):166-74. doi: 10.1016/j.clinthera.2008.01.018.

Reference Type: RESULT

PMID: 18343253 (View on PubMed)

Other Identifiers

00267111

Identifier Type: REGISTRY

Identifier Source: secondary_id

01-0086-E

Identifier Type: -

Identifier Source: org_study_id