NCT00267111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Jul 2003

Typical duration for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

April 23, 2012

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

December 15, 2005

Results QC Date

August 10, 2011

Last Update Submit

July 9, 2024

Conditions

Pain

Keywords

Infant,newbornTopical anesthesiaIntramuscular injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Visual Analogue Scale

    During the entire procedure

Study Arms (2)

Amethocaine gel 4% Group

EXPERIMENTAL

1 g of topical amethocaine gel 4%

Drug: Amethocaine gel 4%

Placebo Group

PLACEBO COMPARATOR
Drug: Eucerin plus

Interventions

Eucerin plusDRUG

1g, single application

Placebo Group
Amethocaine gel 4%DRUG

1 g, single application

Also known as: Ametop
Amethocaine gel 4% Group

Eligibility Criteria

Age24 Hours - 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term neonates \> 37 weeks and
  • Birth weight \> 2500 grams (appropriate for gestational age - AGA) -

You may not qualify if:

  • Neonates with major congenital anomalies
  • Neonates with known neurological abnormalities (antenatally diagnosed)
  • Neonates who require admission to the neonatal intensive care unit at birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related 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.

    PMID: 18343253RESULT

MeSH Terms

Conditions

Pain

Interventions

eucerinTetracaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Dr. Vibhuti Shah
Organization
Mount Sinai Hospital
vshah@mtsinai.on.ca
416-586-4816

Study Officials

  • Vibhuti S Shah, MD, FRCPC

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Neonatologist

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 20, 2005

Study Start

July 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

July 30, 2024

Results First Posted

April 23, 2012

Record last verified: 2024-07

Locations

CA(1)