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

Phase 4

Completed

• Conditions: Post-tonsillectomy pain; Signs and Symptoms; Post-surgical pain

• Registration Number: ISRCTN59862351
• Lead Sponsor: orth West Wales NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-16
• Study Completion: 2009-10-30
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Clinical efficacy: the buprenorphine : creatinine ratio<br> 2. Perceived pain: measurements on the Visual Analogue Scale (VAS)<br> 3. Coping strategies: the compounded prevalent strategy<br><br> All outcomes will be measured at day 10 of the intervention.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Use (dose/frequency) of rescue medication<br> 2. Readmission rate<br> 3. Post-operative haemorrhage rate<br><br> All outcomes will be measured at day 10 of the intervention.<br>