Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Sponsor
Institute of Child Health (Other)
Overall Status
Completed
CT.gov ID
NCT00386269
Collaborator
(none)
44
1
44
1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Official Title:
Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Study Start Date
:
Jan 1, 2004
Actual Study Completion Date
:
Sep 1, 2007
Outcome Measures
Primary Outcome Measures
- Dose of morphine used within the first 6h after surgery []
Secondary Outcome Measures
- Pain scores []
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Months
to 8 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Infants with cleft palate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Great Ormond Street Hospital, Anaesthetics | London | United Kingdom | WC1N 1EH |
Sponsors and Collaborators
- Institute of Child Health
Investigators
- Principal Investigator: Mike Sury, Dr, Institute Of Child Health and Great Ormond Street Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00386269
Other Study ID Numbers:
- 02AR53
First Posted:
Oct 11, 2006
Last Update Posted:
Nov 29, 2007
Last Verified:
Nov 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: