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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386269
First Posted: October 11, 2006
Last Update Posted: November 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Child Health
October 10, 2006
October 11, 2006
November 29, 2007
January 2004
Not Provided
Dose of morphine used within the first 6h after surgery
Same as current
Complete list of historical versions of study NCT00386269 on ClinicalTrials.gov Archive Site
Pain scores
Same as current
Not Provided
Not Provided
 
Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Cleft Palate Repair
Drug: Codeine Phosphate Analgesia
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2007
Not Provided

Inclusion Criteria:

  • Infants with cleft palate
Sexes Eligible for Study: All
4 Months to 8 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00386269
02AR53
Not Provided
Not Provided
Not Provided
Dr Tracy Assari, Institute of Child Health
Institute of Child Health
Not Provided
Principal Investigator: Mike Sury, Dr Institute Of Child Health and Great Ormond Street Hospital
Institute of Child Health
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP