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| 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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN59862351 |
| Date ISRCTN assigned | 16/04/2008 |
| Local reference number(s) | Puranik 07/03/23 |
| Public title | 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 |
| 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 |
| Acronym | PATCH Trial |
| Disease/condition/study domain | Post-tonsillectomy pain |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics approval received from North East Wales Research Ethics Committee (REC) on the 31st January 2008 (ref: 07/WNo03/23). Medicines and Healthcare products Regulatory Agency (MHRA) approval received on the 21st December 2007. |
| Countries of trial | United Kingdom |
| Participants - 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]) |
| Participants - 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 |
| Patient information material | Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet |
| Anticipated start date | 15/11/2007 |
| Anticipated end date | 30/10/2009 |
| Status of trial | Ongoing |
| Target number of participants | 150 in each arm, 300 in total |
| Interventions | 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 |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Sources of funding | North West Wales NHS Trust (UK) - Pathology Research Fund |
| Sponsor name | North West Wales NHS Trust (UK) |
| Sponsor details | c/o Dr. P. Birch Ysbyty Gwynedd Bangor United Kingdom LL57 2PW |
| Sponsor website | http://www.northwestwales.org/ |
| Contact name | Mr Viswanath Puranik |
| Contact details | North West Wales NHS Trust ENT Department Ysbyty Gwynedd Bangor United Kingdom LL57 2PW |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN59862351 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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