A comparison of co-codamol and modified-release morphine sulphate for step-down analgesia in patients following thoracotomy
| ISRCTN | ISRCTN52893628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52893628 |
| Secondary identifying numbers | N0201184743 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 28/08/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
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
Prof Peter Goldstraw
Scientific
Scientific
Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
| Phone | +44 (0)20 7352 8121 |
|---|---|
| P.Goldstraw@rbh.nthames.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. The purpose of this study is to find out whether co-codamol or modified-release morphine provide better post-operative pain control following thoracotomy. 2. The secondary objective is to compare the incidence of complications and compare the compliance of the two analgesia regimens. Common complications include nausea, vomiting, pruritis (itchiness), sedation, lightheadedness, mobility and constipation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | Patients undergoing thoracotomy for the first time and not taking regular analgesia for another condition can be considered for this study. Analgesia in the immediate post-operative period will be decided by consensus of surgeon, anaesthetist and the patient. They include epidural analgesia, PVB (paravertebral continuous analgesia) catheter and intravenous morphine either by continuous infusions or PCA. Every effort is made to ensure satisfactory pain relief. Oral analgesia is commenced at least four hours before the paravertebral, epidural or IV morphine is stopped. Patients will be randomised, by opening an envelope, into one of two groups to determine which of the two regimens they will receive: Group 1: Co-codamol 30/500 2 tablets QDS PO. And unless contraindicated*: Diclofenac 75mg SR BD PO. For breakthrough pain: Tramadol 50−100mg QDS/PRN PO Group 2: Paracetamol 1g QDS PO, MST Continus 20mg BD PO. And unless contraindicated*: Diclofenac 75mg SR bd PO. For breakthrough pain: Oramorph 10mg 1hrly/PRN PO The MST dose should be adjusted on the second day to incorporate the 24 hour oramorph requirement. * The contraindications for NSAIDs are gastroduodenal disease, renal impairment or a poor urine output. When used, patients should also receive omeprazole 20mg OD for gastric protection. Added 28 August 2008: trial stopped due to poor recruitment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | co-codamol and modified-release morphine sulphate |
| Primary outcome measure | 1. Adequacy of pain control as measured by the visual analogue scale (0=no pain, 10=excruciating) 2. How frequently breakthrough analgesia is used overall satisfaction of pain control |
| Secondary outcome measures | Complications: nausea/vomiting, sedation, constipation, pruritis, mobility and compliance |
| Overall study start date | 21/06/2006 |
| Completion date | 01/04/2008 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 60 patients |
| Key inclusion criteria | 1. Patients >18 years 2. First-time thoracotomy patient 3. Informed consent |
| Key exclusion criteria | 1. Patients <18 years 2. Pregnancy 3. Breast-feeding 4. Not able to give informed consent 5. Already taking analgesia at time of admission |
| Date of first enrolment | 21/06/2006 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Brompton & Harefield NHS Trust
London
SW3 6NP
United Kingdom
SW3 6NP
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Royal Brompton and Harefield NHS Trust (UK), No External Funding, NHS R&D Support Funding
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 |
