Morbidity associated with perioperative intravenous fluid in children undergoing tonsillectomy
| ISRCTN | ISRCTN26015483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26015483 |
| Secondary identifying numbers | N0065091703 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 18/08/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Ear, Nose and Throat
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 D Laws
Scientific
Scientific
Department of Anaesthesia
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
| Phone | +44 (0)191 5656256 ext 42446 |
|---|---|
| david.laws@chs.northy.nhs.uk |
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 | To see whether giving a bolus of 20 ml intravenous dextrose 4%/saline 0.18% fluid reduces postoperative nausea and vomiting in children undergoing tonsillectomy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ear, Nose and Throat: Tonsillectomy |
| Intervention | Randomised controlled trial, patient, parent and ward nurses blinded to limb allocation, half the study group will receive a measured amount of intravenous fluid during the operation and half will not receive this intravenous fluid. |
| Intervention type | Other |
| Primary outcome measure | The incidence and severity of vomiting, pain and activity disturbance will be monitored and recorded for 3 days post surgery. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2001 |
| Completion date | 01/07/2003 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 15 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Children aged between 2 and 15 years, both male and female undergoing tonsillectomy will be recruited. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
Sunderland
SR4 7TP
United Kingdom
SR4 7TP
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
City Hospitals Sunderland 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 |
