Pain relief in children after day-case tonsillectomy.
| ISRCTN | ISRCTN59683871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59683871 |
| Protocol serial number | N0112133830 |
| Sponsor | Department of Health |
| Funder | Epsom and St Helier University Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 26/05/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
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 Lenny Ng
Scientific
Scientific
Epsom and St Helier University Hospitals NHS Trust
Department of Anaesthesia
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
| Phone | +44 (0)208 296 2444 |
|---|---|
| Lenny.ng@doctors.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The provision of a painkiller chart to parents of children undergoing tonsillectomy does not reduce pain and improve recovery in children after the procedure. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Post-operative pain |
| Intervention | Please note that as of 26/05/10 the status of this trial was changed to "stopped". The trial was discontinued due to lack of funding. 1. Parents of the child booked in for day case tonsillectomy will receive a Patients Information Sheet at their out-patients appointment 2. The anaesthetist concerned will obtain consent for participation in the study from the child's parent on the morning of the surgery 3. The children will be randomised by St Helier on the day surgery unit 4. They will receive a standard anaesthetic and have routine monitoring 5. The children will have routine recovery care 6. They will have standard painkillers to take home with written instructions on bottle 7. Information on discharge: anaesthetist tells parents to give analgesia regularly to their child, even if not in pain. Both groups to receive pain score and recovery indicator questionnaire 8. One group will receive a "painkiller chart" and the control group will not 9. Parents will receive telephone call on day 1, 3 and 7 after tonsillectomy to remind them to fill out questionnaire. 10. Questionnaire will be collected at the two week follow-up clinic by Mr Rathod, Ear, Nose and Throat (ENT) Surgeon |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Pain scores as measured on two separate visual analogue scales |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2004 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 10 Years |
| Sex | All |
| Key inclusion criteria | 1. Will be aged 5-10 years 2. Will be undergoing tonsillectomy as a day case procedure at Queen Mary's Hospital Day Theatre 3. Will be healthy children, American Society of Anesthesiologists (ASA) I and II |
| Key exclusion criteria | Children already on analgesics, children who have a contraindication or allergy to ibuprofen/paracetamol and children who experience unexpected complications perioperatively. |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 31/08/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Epsom and St Helier University Hospitals NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
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 |
