Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
26/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lenny Ng

ORCID ID

Contact details

Epsom and St Helier University Hospitals NHS Trust
Department of Anaesthesia
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
+44 (0)208 296 2444
Lenny.ng@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0112133830

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2003

Overall trial end date

31/08/2004

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Children already on analgesics, children who have a contraindication or allergy to ibuprofen/paracetamol and children who experience unexpected complications perioperatively.

Recruitment start date

01/09/2003

Recruitment end date

31/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Epsom and St Helier University Hospitals NHS Trust
Carshalton
SM5 1AA
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Epsom and St Helier University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes