Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr D Parker

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
ENT Department
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
+44 (0)1332 347141 ext 2563

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077117132

Study information

Scientific title

Acronym

Study hypothesis

Coblator tonsillectomy in children produces less post operative pain than the use of conventional surgical techniques.
Randomised entry. Computer generated-opaque envelope same surgeon/anesthetist removal of tonsils either by conventional steel reusable tonsillectomy instruments or disposable coblator wand. Validated pain charts to assess pain scores - Wong and Baker in 24 h post operation as inpatient.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Pain

Intervention

Removal of tonsils either by conventional steel reusable tonsillectomy instruments or disposable coblator wand

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

1. Pain scores days 1, 2, 4, 7 and 10 days
2. Analgesia requirements 1, 2, 4, 7 and 10 days
3. Dietary intake - return to normal diet point

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2002

Overall trial end date

05/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 4-12 undergoing tonsillectomy from Mr Parker's waiting list at the Children's Hospital.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2002

Recruitment end date

05/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Southern Derbyshire Acute 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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19531171

Publication citations

  1. Results

    Parker D, Howe L, Unsworth V, Hilliam R, A randomised controlled trial to compare postoperative pain in children undergoing tonsillectomy using cold steel dissection with bipolar haemostasis versus coblation technique., Clin Otolaryngol, 2009, 34, 3, 225-231, doi: 10.1111/j.1749-4486.2009.01932.x.

Additional files

Editorial Notes