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 |
| Protocol serial number | N0205128954 |
| Sponsor | Department of Health |
| Funder | Barts and The London NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Incidence of nausea and vomiting |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Anaesthetic Dept
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |