Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants

Tracking Information
First Submitted Date ICMJE	October 10, 2006
First Posted Date ICMJE	October 11, 2006
Last Update Posted Date	November 29, 2007
Study Start Date ICMJE	January 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: October 10, 2006)	Dose of morphine used within the first 6h after surgery
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00386269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 10, 2006)	Pain scores
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Official Title ICMJE	Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double
Condition ICMJE	Cleft Palate Repair
Intervention ICMJE	Drug: Codeine Phosphate Analgesia
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: October 10, 2006)	44
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2007
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Infants with cleft palate
Sex/Gender	Sexes Eligible for Study: All
Ages	4 Months to 8 Months (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00386269
Other Study ID Numbers ICMJE	02AR53
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr Tracy Assari, Institute of Child Health
Study Sponsor ICMJE	Institute of Child Health
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Mike Sury, Dr Institute Of Child Health and Great Ormond Street Hospital
PRS Account	Institute of Child Health
Verification Date	November 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP