Pain relief in children after day-case tonsillectomy.

ISRCTN	ISRCTN59683871
DOI	https://doi.org/10.1186/ISRCTN59683871
Secondary identifying numbers	N0112133830

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

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
Email	Lenny.ng@doctors.org.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	1. Pain scores as measured on two separate visual analogue scales 2. Recovery indicators i.e. time to normal diet, time to normal sleeping patterns, nausea and vomiting and need to ring hospital/GP for advice regarding pain control
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2003
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	Both
Target number of participants	Not provided at time of registration
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

England
United Kingdom

Study participating centre

Epsom and St Helier University Hospitals NHS Trust

Carshalton
SM5 1AA
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Epsom and St Helier University 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