Double-blind randomised study into the efficacy of codeine phosphate analgesia after cleft palate repair in infants
| ISRCTN | ISRCTN86816150 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86816150 |
| Protocol serial number | N0012128260 |
| Sponsor | Department of Health |
| Funders | Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health, Association of Paediatric Anaesthetists |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M R J Sury
Scientific
Scientific
Anaesthetics
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Double-blind randomised study into the efficacy of codeine phosphate analgesia after cleft palate repair in infants |
| Study objectives | How effective is codeine phosphate after cleft palate repair in infants and how much is metabolised to morphine in this age group? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cleft palate repair |
| Intervention | 1. Codeine phosphate after cleft palate repair 2. No codeine phosphate |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Codeine phosphate |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Key inclusion criteria | Children who have cleft palate |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/11/2016: No publications found, verifying study status with principal investigator.
