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NCT Number: NCT00267111

Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

24 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eucerin plus

Drug

1g, single application

Amethocaine gel 4%

Drug

1 g, single application

Other names: Ametop

Primary outcomes

  1. 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.

    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 outcomes

  1. Visual Analogue Scale

    Time frame: During the entire procedure

    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.

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • Striving for Excellence Fund, Mount Sinai Hospital

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 20, 2005
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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