Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
Study Details
Study Description
Brief Summary
RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known whether one drug is more effective than the other in lessening pleurodesis-related pain or whether the size of the chest drain tube affects pain.
PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works compared with morphine in treating pain in patients undergoing pleurodesis for malignant pleural effusion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
-
To evaluate the efficacy of a non-steroidal based regimen comprising ibuprofen in decreasing post-pleurodesis pain as compared to an opiate-based regimen comprising morphine sulfate in patients with malignant pleural effusion.
-
To evaluate whether chest drain size influences the amount of post-pleurodesis pain.
OUTLINE: This is a multicenter study. Patients are stratified according to histological tissue type (mesothelioma vs non-mesothelioma) and thoracoscopic procedure. Patients are randomized to 1 of 4 treatment arms.
-
Arm I: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
-
Arm II: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
-
Arm III: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.
-
Arm IV: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.
All patients will receive regular background analgesia comprising paracetamol 4 times daily on days 0-3. Patients not adequately treated with these regimens may also receive rescue analgesia comprising morphine sulfate IV on days 0-3.
After completion of study treatment, patients are followed at 1, 3, and 6 months, and periodically thereafter.
Study Design
Outcome Measures
Primary Outcome Measures
- Average pain score over 72 hours post pleurodesis (total pain relief score) by a Visual Analogue Scale of pain relief and pain intensity every 6 hours []
- Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion, censored for survival) []
Secondary Outcome Measures
- Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization []
- Change in hemoglobin and white cell count from day 0 to day 3 []
- Change in renal function and liver function (i.e., ALT or AST, bilirubin, albumin, and alk phos) from day 0 to day 3 []
- Change in Inflammatory markers from day 0 and day 3 (e.g., CRP, WCC) from day 0 to day 3 []
- Change in alveolar PO2-arterial PO2 (A-a) gradient (on air) on day 0 and day 3 []
- Continuous oximetry monitoring from day 0 to day 3 (on air unless saturation < 90%) []
- Average conscious level measured by Glasgow Coma scale from day 0 to day 3 []
- Drug- and talc-related adverse reactions []
- Complications from chest drain insertion []
- Presence of chronic chest wall pain assessed at all follow-up visits []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following:
-
Histologically proven pleural malignancy
-
Typical features of pleural malignancy seen on direct vision during thoracoscopy
-
Pleural effusion in the context of histologically proven cancer elsewhere
-
No primary lymphoma or small cell lung carcinoma
-
All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible
PATIENT CHARACTERISTICS:
-
Life expectancy > 1 month
-
Not pregnant or nursing
-
No history of GI bleeding or untreated peptic ulceration
-
No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol
-
No hypercapnic respiratory failure
-
No known intravenous drug abuse
-
No severe renal or liver disease
-
No known bleeding diathesis
-
Able to give informed consent
PRIOR CONCURRENT THERAPY:
-
More than 2 weeks since prior and no concurrent corticosteroid therapy
-
No concurrent warfarin therapy
-
No other concurrent analgesics
-
Analgesics used as a breakthrough regimen are allowed from trial entry to tube withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study analgesia, and breakthrough medication only, including opiate slow release patches)
-
No concurrent enrollment on another clinical study
-
Patients may participate in other trials immediately after completion of current trial, excluding those involving further pleural procedures or analgesia trials in which patients must wait at least 3 months after completion of current trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oxford Radcliffe Hospital | Oxford | England | United Kingdom | 0X3 9DU |
Sponsors and Collaborators
- Oxford University Hospitals NHS Trust
Investigators
- Principal Investigator: Robert Davies, MD, Oxford University Hospitals NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000590072
- RADCLIFFE-TIME1
- ISRCTN33288337
- EUDRACT 2006-005226-31
- EU-20829
- UKCRN 4035