Is Trimeprazine effective in managing retching following Nissen fundoplication?
| ISRCTN | ISRCTN47286039 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47286039 |
| Secondary identifying numbers | N0012120117 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B Antao
Scientific
Scientific
Surgery
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
| Phone | +44 (0)20 7405 9200 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Nissen fundoplication |
| Intervention | Random allocation to (A) Retching treatment (B) Standard care. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Trimeprazine |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2002 |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Children who have had Nissen fundoplication. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Surgery
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (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 | 01/11/2005 | Yes | No |
