Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
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ClinicalTrials.gov Identifier: NCT00386269 |
Recruitment Status
:
Completed
First Posted
: October 11, 2006
Last Update Posted
: November 29, 2007
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Sponsor:
Institute of Child Health
Information provided by:
Institute of Child Health
Tracking Information | ||||
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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 |
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 |
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 |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
44 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | September 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender |
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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 |
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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 |