Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
November 28, 2007 updated by: Institute of Child Health
This study examines the analgesic efficacy of codeine phosphate.
It is compared to placebo in infants receiving morphine after surgery.
Codeine may be effective enough to make morphine unnecessary.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, WC1N 1EH
- Great Ormond Street Hospital, Anaesthetics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 8 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants with cleft palate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Dose of morphine used within the first 6h after surgery
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Secondary Outcome Measures
Outcome Measure |
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Pain scores
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mike Sury, Dr, Institute Of Child Health and Great Ormond Street Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
October 10, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (Estimate)
October 11, 2006
Study Record Updates
Last Update Posted (Estimate)
November 29, 2007
Last Update Submitted That Met QC Criteria
November 28, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Cleft Palate
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Codeine
Other Study ID Numbers
- 02AR53
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.