Comparative study of pain levels following paediatric tonsillectomy using either conventional tonsillectomy instruments or the coblator device for tonsil removal

ISRCTN	ISRCTN07513663
DOI	https://doi.org/10.1186/ISRCTN07513663
Protocol serial number	N0077117132
Sponsor	Department of Health (UK)
Funder	Southern Derbyshire Acute Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr D Parker
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
ENT Department
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Phone	+44 (0)1332 347141 ext 2563

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	05/08/2004

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	12 Years
Sex	Not Specified
Key inclusion criteria	Children aged 4-12 undergoing tonsillectomy from Mr Parker's waiting list at the Children's Hospital.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2002
Date of final enrolment	05/08/2004

Southern Derbyshire Acute Hospitals NHS Trust

Derby
DE1 2QY
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No