Phase 2 N=110 Randomized Quadruple-blind Treatment

Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

Pain

Bottom Line

View on ClinicalTrials.gov: NCT00267111 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Apr 2012

Primary outcome: Primary: Pain Scores Assessed by Neonatal Facial Action — 14; 18; 30; 44 Percentage of time — p=< 0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Eucerin plus (Drug); Amethocaine gel 4% (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Mount Sinai Hospital, Canada
Primary completion: Dec 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Scores Assessed by Neonatal Facial Action	14; 18; 30; 44; 70; 75	< 0.05 sig
SECONDARY Visual Analogue Scale	4.6; 4.6; 5.0; 4.9	<0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00267111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.