Additional identifiers
EudraCT number
2007-006117-16
ClinicalTrials.gov number
Protocol/serial number
Puranik 07/03/23
Study information
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
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.
Ethics approval
North East Wales Research Ethics Committee (REC), 31/01/2008, ref: 07/WNo03/23
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet
Condition
Post-tonsillectomy pain
Intervention
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
Intervention type
Drug
Phase
Phase IV
Drug names
Buprenorphine (Transtec®), codeine phosphate hemihydrate, paracetamol (Solpadol®)
Primary outcome measure
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 measures
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.
Overall trial start date
15/11/2007
Overall trial end date
30/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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])
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150 in each arm, 300 in total
Participant 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
Recruitment start date
15/11/2007
Recruitment end date
30/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North West Wales NHS Trust
Bangor
LL57 2PW
United Kingdom
Sponsor information
Organisation
North West Wales NHS Trust (UK)
Sponsor details
c/o Dr. P. Birch
Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North West Wales NHS Trust (UK) - Pathology Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list