Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
Recruitment status was: Recruiting
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.
|Metastatic Cancer||Drug: ibuprofen Drug: morphine sulfate Procedure: management of therapy complications Procedure: pleurodesis||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A 2 x 2 Factorial Trial to Assess Whether Non-Steroidal Anti-Inflammatory Analgesics and Small Bore Chest Tubes Are Less Painful Than Opiate Analgesics and a Large Bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion [TIME1]|
- 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)
- 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
|Study Start Date:||March 2007|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644319
|Oxford Radcliffe Hospital||Recruiting|
|Oxford, England, United Kingdom, 0X3 9DU|
|Contact: Contact Person 44-1865-225-205 email@example.com|
|Principal Investigator:||Robert Davies, MD||Oxford University Hospitals NHS Trust|