post-tonsillectomy pain
Conditions
Interventions
Trade Name: BuTrans® 20 µg/h Transdermal Patch
Product Name: BuTrans® 20 µg/h transdermal patch
Product Code: n/a
Pharmaceutical Form: Transdermal patch
Sponsors
Betsi Cadwaladr University Health Board
Eligibility
Sex/Gender
All
Inclusion 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
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; • patients suffering from myasthenia gravis; • patients suffering from delirium tremens or acute alcohol intoxication; • convulsive disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this research is to establish whether post-tonsillectomy analgesia using a transdermal patch has benefits over currently used oral analgesia;Secondary Objective: n/a;Primary end point(s): the first self reported day when analgesia was no longer needed | — |
Countries
United Kingdom
Outcome results
None listed