Comparison of codeine phosphate and morphine sulphate in infants undergoing cleft palate repair
| ISRCTN | ISRCTN86833416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86833416 |
| Protocol serial number | N0190133718 |
| Sponsor | Department of Health |
| Funder | Queen Victoria Hospital NHS Foundation Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 07/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Steven Fenlon
Scientific
Scientific
The Queen Victoria Hospital NHS Trust
Holtye Road
East Grinstead
RH19 3DZ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Comparative, randomised, controlled clinical study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare two commonly used analgesic regimes, intravenous morphine versus intramuscular codeine, in controlling immediate post-operative pain following surgery for primary cleft palate repair. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cleft palate repair |
| Intervention | Infants received one of two analgesics intraoperatively for immediate postoperative pain relief. Morphine was given by intravenous injection and codeine by the intramuscular route. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Morphine, codeine |
| Primary outcome measure(s) |
Pain scores in the immediate postoperative period for 2 hours following surgery - is morphine better/same/worse than established regimes? |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | Infants having primary cleft palate repair with informed parental consent to enter the study. |
| Key exclusion criteria | Does not comply with above inclusion criteria |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Queen Victoria Hospital NHS Trust
East Grinstead
RH19 3DZ
United Kingdom
RH19 3DZ
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? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2007 | Yes | No |
