Double blind randomised study into the efficacy of Codeine Phosphate analgesia after cleft palate repair in infants
| DEC-NET Serial number GB277 | |
| Published online | 07/07/2004 13.13.00 |
| Last updated | 02/08/2005 14.00.32 |
| Other protocol ID number | N0012128260 |
| This trial has been approved by an ethics committee | |
| Current trial status | Open (actively recruiting new participants) |
| Major Disease (ICD9 class) | CLEFT PALATE NOS |
| Experimental drug | |
| Codeine Phosphate | |
| Gender | Both |
| Age (range) | 0 -2 years |
Eligibility criteria | |
| Inclusion criteria | |
| Infants with cleft palates undergoing surgical repair | |
| Exclusion criteria | |
| Informed consent not given | |
Trial design/methodology | |
| Phase | 4 |
| Kind of study | Efficacy Pharmacokinetics |
| Design | Controlled Randomised Blinded Double blind |
| Purpose of study | |
| To determine the efficacy of Codeine Phosphate after cleft palate repair in infants, and to determine how much is metabolised to morphine in this age group | |
| Primary outcomes | |
| Reduction in pos-operative pain | |
| Secondary outcomes | |
| Metabolism to Morphine | |
| Summary of study design, objectives, and ongoing research findings | |
| Double blind randomised study. Random allocation (A) Codeine phosphate after cleft palate repair (B) No codeine phosphate . | |
| Principal investigator | |
| Name | Dr MRJ Sury |
| Institution | Great Ormond Street Hospital |
| Postal address | Anaesthetics, Great Ormond Street Hospital, Great Ormond Street, London, WC1N 3JH |
| City | London |
| Country | UNITED KINGDOM |
| Phone | 020 7405 9200 Ext 5399 |
| Fax | |
| ISRCTN | EudraCT |
