Prophylaxis against Postoperative Vomiting (PaPoV) study: a prospective, controlled randomised double-blind trial comparing antiemetic prophylaxis with ondansetron, cyclizine and placebo (normal saline) in children undergoing plastic genito-urinary (GU) procedures
| ISRCTN | ISRCTN08630314 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08630314 |
| Secondary identifying numbers | N0557102800 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 09/07/2009
- 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 Philip Whitehurst
Scientific
Scientific
Consultant Anaesthetist
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
Study information
| Study design | Randomised double blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PaPoV |
| Study objectives | To assess the incidence of postoperative vomiting in children undergoing genital plastic surgery in a prospective, randomised, double blind study comparing ondansetron with cyclizine and placebo (normal saline). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Vomiting |
| Intervention | Prospective, controlled randomised double-blind trial. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | ondansetron cyclizine |
| Primary outcome measure | Number of vomits in the first 24 h from the time of extubation; doses of anti-emetics given because of vomiting in the first 24 h; time to first oral intake; complications (obtained retrospectively from case notes). |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1997 |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 110 |
| Key inclusion criteria | Children undergoing elective plastic genito-urinary procedures between the ages of 3 and 5, American Society of Anesthesiologists (ASA) grade I & II. 55 Children in each group. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Anaesthetist
Dudley
DY1 2HQ
United Kingdom
DY1 2HQ
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
Hospital/treatment centre
The Dudley Group of Hospitals NHS 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 | 01/07/2003 | Yes | No |
