Condition category
Signs and Symptoms
Date applied
24/10/2007
Date assigned
16/04/2008
Last edited
27/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Viswanath Puranik

ORCID ID

Contact details

North West Wales NHS Trust
ENT Department
Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom

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 measures

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

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

http://www.northwestwales.org/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/04/2016: No publications found, verifying study status with principal investigator