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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19531171
Publication citations
-
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.