Does the administration of intravenous (IV) fluids intra-operatively reduce the incidence of post-operative nausea and vomiting in children undergoing day-surgery?
| ISRCTN | ISRCTN89982548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89982548 |
| Secondary identifying numbers | N0205128954 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 24/09/2013
- 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 S Bhatia
Scientific
Scientific
Anaesthetic Dept
Royal London Hospital
Whitechapel
London
E1 1BB
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 | Prevention |
| Scientific title | |
| Study objectives | Does the administration of IV fluids intra-operatively reduce the incidence of post-operative nausea and vomiting in children undergoing day-surgery? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nausea and vomiting; surgery |
| Intervention | Randomised double blind controlled trial Group 1: Children will receive 20 ml/kg of IV compound sodium lactate solution intra-operatively Group 2: Children will receive no intravenous fluid intra-operatively |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Incidence of nausea and vomiting |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2003 |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 300 children between 2 and 12 years |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetic Dept
London
E1 1BB
United Kingdom
E1 1BB
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
Barts and The London 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 |
