EUCTR2007-006117-16-GB
Active, not recruiting
Phase 1
A prospective, randomised, phase IV, open label clinical trial to study the therapeutic use of buprenorphine 20 mg (BuTrans 20µg/h) matrix transdermal patch in the management of post tonsillectomy pain in adults - PATCH Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Betsi Cadwaladr University Health Board
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing tonsillectomy, which meet the following criteria:
- •aged 18 to 50 years old;
- •ASA grade I \& II \- healthy patient; mild systemic disease with no functional limitation (e.g. well controlled HTA)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •age less than 18 or over 50;
- •ASA grade III \- severe systemic disease with definite functional limitation e.g. unstable angina)
- •conditions in which the respiratory centre and function are severely impaired or may become so;
- •asthmatic and allergic to NSAIDS;
- •hypotension
- •pregnancy and lactation;
- •recent head injury;
- •known hypersensitivity towards the active substance buprenorphine or to any of the excipients (for the excipients see section 6\.1\);
- •in opioid\-dependent patients and for narcotic withdrawal treatment;
- •patients who are receiving MAO inhibitors or have taken them within the last two weeks;
Outcomes
Primary Outcomes
Not specified
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