Comparison of codeine phosphate and morphine sulphate in infants undergoing cleft palate repair
| ISRCTN | ISRCTN86833416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86833416 |
| Secondary identifying numbers | N0190133718 |
- 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
| Study design | Comparative, randomised, controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Morphine, codeine |
| Primary outcome measure | Pain scores in the immediate postoperative period for 2 hours following surgery - is morphine better/same/worse than established regimes? |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/10/2003 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
The Queen Victoria Hospital NHS Trust
East Grinstead
RH19 3DZ
United Kingdom
RH19 3DZ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Queen Victoria Hospital NHS Foundation Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
