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
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 design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/09/2002 |
| Completion date | 05/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Sponsor information
Department of Health (UK)
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
