Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

Pain Clinical Trial

Official title:

Local Anaesthesia [Topical Amethocaine Gel (Ametop)] for Intramuscular Injection in Term Neonates: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267111
• Other study ID #: 01-0086-E
• Secondary ID: 00267111
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2005
• Last updated: March 28, 2012
• Start date: July 2003
• Est. completion date: December 2004

Study information

• Verified date: March 2012
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Eucerin plus
1g, single application
• Amethocaine gel 4%
1 g, single application

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Striving for Excellence Fund, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores Assessed by Neonatal Facial Action	The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted < 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.	For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds.	No
Secondary	Visual Analogue Scale	Parents and nurses were asked to assess the infant's pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0="no pain" on the left side and 10="worst possible pain" on the right side. Parents and nurses were trained to use the VAS prior to the IM injection.	During the entire procedure	No