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 |
| Secondary identifying numbers | N0012128260 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Codeine phosphate |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2003 |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
WC1N 3JH
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
Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health
No information available
Association of Paediatric Anaesthetists
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 |
Editorial Notes
02/11/2016: No publications found, verifying study status with principal investigator.
