Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Amethocaine gel 4%; Drug: Eucerin plus

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Drug: Eucerin plus; 1g, single application
Experimental: Amethocaine gel 4% Group; 1 g of topical amethocaine gel 4%	Drug: Amethocaine gel 4%; 1 g, single application; Other Names: Ametop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: Striving for Excellence Fund, Mount Sinai Hospital
• Investigators: Principal Investigator: Vibhuti S Shah, MD, FRCPC, Mount Sinai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: December 15, 2005
• First Submitted That Met QC Criteria: December 19, 2005
• First Posted (Estimate): December 20, 2005

Study Record Updates

• Last Update Posted (Estimate): April 23, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Topical anesthesia; Intramuscular injection; Infant,newborn
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Tetracaine
• Other Study ID Numbers: 01-0086-E; 00267111 (Registry Identifier: www.clinicaltrials.gov)