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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00267111 |
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Date of registration:
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15/12/2005 |
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Primary sponsor: |
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Public title:
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Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
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Scientific title:
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Local Anaesthesia [Topical Amethocaine Gel (Ametop)] for Intramuscular Injection in Term Neonates: A Randomized Controlled Trial. |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00267111 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Vibhuti S Shah, MD, FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mount Sinai Hospital, New York |
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Key inclusion & exclusion criteria
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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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Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Drug: Amethocaine gel 4%
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Drug: Eucerin plus
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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Visual Analogue Scale
[Time Frame: During the entire procedure]
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Secondary ID(s)
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00267111
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01-0086-E
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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