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
Secondary identifying numbers N0077117132
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
24/11/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesCoblator 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) studiedSigns and Symptoms: Pain
InterventionRemoval of tonsils either by conventional steel reusable tonsillectomy instruments or disposable coblator wand
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/09/2002
Completion date05/08/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit12 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaChildren aged 4-12 undergoing tonsillectomy from Mr Parker's waiting list at the Children's Hospital.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2002
Date of final enrolment05/08/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Southern Derbyshire Acute Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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