ISRCTN59862351CompletedPhase 4
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
orth West Wales NHS Trust (UK)0 sites133 target enrollmentStarted: April 16, 2008Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 133
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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])
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
Investigators
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