Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
This study has been completed.
Sponsor:
Institute of Child Health
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00386269
First received: October 10, 2006
Last updated: November 28, 2007
Last verified: November 2007
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | October 10, 2006 | |||
| Last Updated Date | November 28, 2007 | |||
| 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-Blind |
|||
| 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 | 44 | |||
| Completion Date | September 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
|||
| Sex/Gender |
|
|||
| 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 | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Dr Tracy Assari, Institute of Child Health | |||
| Study Sponsor ICMJE | Institute of Child Health | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
|
|||
| Information Provided By | 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 |
||||