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Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

This study has been completed.
Sponsor:
Collaborator:
Striving for Excellence Fund, Mount Sinai Hospital
Information provided by (Responsible Party):
Vibhuti Shah, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00267111
First received: December 15, 2005
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
 Drug: Eucerin plus
Drug: Amethocaine gel 4%
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Anaesthesia [Topical Amethocaine Gel (Ametop)] for Intramuscular Injection in Term Neonates: A Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Pain Scores Assessed by Neonatal Facial Action [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: During the entire procedure ] [ Designated as safety issue: No ]
    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.


Enrollment: 110
Study Start Date: July 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amethocaine gel 4% Group
1 g of topical amethocaine gel 4%
 Drug: Amethocaine gel 4%
1 g, single application
Other Name: Ametop
Placebo Comparator: Placebo Group Drug: Eucerin plus
1g, single application
Other Name: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267111

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Striving for Excellence Fund, Mount Sinai Hospital
Investigators
Principal Investigator: Vibhuti S Shah, MD, FRCPC Mount Sinai Hospital, New York
  More Information

Publications:

Responsible Party: Vibhuti Shah, Staff Neonatologist, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT00267111     History of Changes
Other Study ID Numbers: 01-0086-E, 00267111
Study First Received: December 15, 2005
Results First Received: August 10, 2011
Last Updated: March 28, 2012
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
Infant,newborn
Topical anesthesia
Intramuscular injection

Additional relevant MeSH terms:
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013