Prospective blinded randomised placebo controlled trial investigating whether oxycodone modified release reduces parenteral opioid use following intermediate thoracic surgery
| ISRCTN | ISRCTN14478115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14478115 |
| Secondary identifying numbers | 03-274 |
- Submission date
- 29/07/2004
- Registration date
- 21/09/2004
- Last edited
- 07/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Royston
Scientific
Scientific
Department of Anaesthesia
Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | Prospective blinded randomised placebo controlled trial investigating whether oxycodone modified release reduces parenteral opioid use following intermediate thoracic surgery |
| Study acronym | OxyPATS |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Post-operative pain following intermediate thoracic surgery |
| Intervention | Oxycodone modified release 10 mg bd or placebo for 48 hrs postoperatively. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oxycodone |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Adult patients scheduled for unilateral intermediate thoracic surgery (e.g. pleural abrasion, talc pleurodesis and lung biopsy) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
Harefield
UB9 6JH
United Kingdom
UB9 6JH
United Kingdom
Sponsor information
Harefield Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Dr CPR Walker
Department of Anaesthesia & Pain Management
Hill End Road
Harefield
UB9 6JH
England
United Kingdom
"ROR" |
https://ror.org/04fwa4t58 |
|---|
Funders
Funder type
Industry
Royal Brompton & Harefield NHS Trust fund the salaries.
No information available
Napp Pharmaceuticals are supplying the study drugs and placebos.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/03/2017: No publications found in PubMed, verifying study status with principal investigator
