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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: |
NCT00713726 |
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Date of registration:
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09/07/2008 |
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Primary sponsor: |
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Public title:
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Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
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Scientific title:
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Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00713726 |
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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: Safety/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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Brazil
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Contacts
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Name:
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Ruth Guinsburg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of São Paulo |
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Name:
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Ana Julia C Alencar |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal university of são Paulo and Albert Sabin Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infant 0-28 days of life with indication of large or medium surgical procedure
(definition according to the American College of Cardiology, American Heart
Association - 2002)
Exclusion Criteria:
- Death or hospital discharge until 72 hours after surgical procedure
- New surgery until 72 hours after the studied surgical procedure
- Proved bacterial infection before surgery
- Ambiguous genitalia
- Chromosomal syndromes
Age minimum:
N/A
Age maximum:
28 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Analgesia
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Neonatal Infections
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Pain
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Intervention(s)
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Drug: FentanyL
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Drug: Tramadol
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Primary Outcome(s)
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Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure
[Time Frame: Every 2-4h during the first 72 hours after surgical procedure]
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Secondary Outcome(s)
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Time between surgical procedure and achievement of 100 mL/kg of enteral feeding
[Time Frame: hospital stay]
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Time between surgical procedure and successful extubation
[Time Frame: Hospital stay]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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