Is buprenorphine patch more effective than standard oral medication in the management of post-tonsillectomy pain: a study on how people cope with the pain following the removal of tonsils
| ISRCTN | ISRCTN59862351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59862351 |
| EudraCT/CTIS number | 2007-006117-16 |
| Secondary identifying numbers | Puranik 07/03/23 |
- Submission date
- 24/10/2007
- Registration date
- 16/04/2008
- Last edited
- 21/04/2020
- 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 Viswanath Puranik
Scientific
Scientific
North West Wales NHS Trust
ENT Department
Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet |
| Scientific title | PATCH Trial: Post-tonsillectomy Analgesia with buprenorphine Transdermal patCH: a prospective, randomised, phase IV, open label clinical trial to study the therapeutic use of buprenorphine 20 mg (Transtec®) matrix transdermal patch in the management of post-tonsillectomy pain in adults |
| Study acronym | PATCH Trial |
| Study objectives | To establish whether post-tonsillectomy analgesia using a transdermal patch has benefits over currently used oral analgesia, by comparatively measuring the clinical efficacy, the effective and perceived pain control, and the rate at which complications and adverse effects occur. |
| Ethics approval(s) | North East Wales Research Ethics Committee (REC), 31/01/2008, ref: 07/WNo03/23 |
| Health condition(s) or problem(s) studied | Post-tonsillectomy pain |
| Intervention | Arm A (interventional): will receive a 12 day supply of buprenorphine 20 mg (35 mg/h) (Transtec®) matrix transdermal patches (a total of four patches). Patients are required to replace the transdermal patch every three days. Arm B (control): will receive a 12-day supply of codeine phosphate 30 mg/ paracetamol 500 mg (30/500/Solpadol®). Patients are required to take two tablets every four hours (p.r.n). Total duration of treatment is 12 days. Final assessment and all data collected at day 10 (outpatient clinic), for both arms, no other follow-up. Please use the following contact details to request a patient information sheet: Dr. Rossela O. Stoicescu Clinical Governance Officer (R&D Manager/Ethics Co-ordinator) North Wales Clinical School - Clinical Academic Office North West Wales NHS Trust Ysbyty Gwynedd Bangor, Gwynedd LL57 2PW |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Buprenorphine (Transtec®), codeine phosphate hemihydrate, paracetamol (Solpadol®) |
| Primary outcome measure | 1. Clinical efficacy: the buprenorphine : creatinine ratio 2. Perceived pain: measurements on the Visual Analogue Scale (VAS) 3. Coping strategies: the compounded prevalent strategy All outcomes will be measured at day 10 of the intervention. |
| Secondary outcome measures | 1. Use (dose/frequency) of rescue medication 2. Readmission rate 3. Post-operative haemorrhage rate All outcomes will be measured at day 10 of the intervention. |
| Overall study start date | 15/11/2007 |
| Completion date | 30/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 in each arm, 300 in total |
| Total final enrolment | 133 |
| Key inclusion criteria | Patients undergoing tonsillectomy, who meet the following criteria: 1. Aged 18 to 50 years old, either sex 2. American Society of Anaesthesiologists (ASA) grade I and II: healthy patient, mild systemic disease with no functional limitation (e.g., well controlled hypertension [HTA]) |
| Key exclusion criteria | 1. Age less than 18 or over 50 years 2. ASA grade III - severe systemic disease with definite functional limitation (e.g., unstable angina) 3. Any condition in which the respiratory centre and function are severely impaired or may become so 4. Asthmatic and allergic to non-steroidal anti-inflammatory drugs (NSAIDS) 5. Hypotension 6. Pregnancy and lactation 7. Recent head injury 8. Known hypersensitivity towards the active substance buprenorphine or to any of the excipients 9. Opioid-dependent patients, or patients in narcotic withdrawal treatment 9. Patients who are receiving monoamine oxidase (MAO) inhibitors or have taken them within the last two weeks 10. Patients suffering from myasthenia gravis 11. Patients suffering from delirium tremens or acute alcohol intoxication 12. Convulsive disorders |
| Date of first enrolment | 15/11/2007 |
| Date of final enrolment | 30/10/2009 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
North West Wales NHS Trust
Bangor
LL57 2PW
United Kingdom
LL57 2PW
United Kingdom
Sponsor information
North West Wales NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr. P. Birch
Ysbyty Gwynedd
Bangor
LL57 2PW
Wales
United Kingdom
| Website | http://www.northwestwales.org/ |
|---|---|
"ROR" |
https://ror.org/04a496k07 |
Funders
Funder type
Government
North West Wales NHS Trust (UK) - Pathology Research Fund
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? |
|---|---|---|---|---|---|
| Basic results | 21/04/2020 | No | No |
Editorial Notes
21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
27/04/2016: No publications found, verifying study status with principal investigator
