Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
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|ClinicalTrials.gov Identifier: NCT00644319|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : March 26, 2008
Last Update Posted : July 8, 2009
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|
|Metastatic Cancer||Drug: ibuprofen Drug: morphine sulfate Procedure: management of therapy complications Procedure: pleurodesis||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|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]|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||September 2009|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644319
|Oxford Radcliffe Hospital||Recruiting|
|Oxford, England, United Kingdom, 0X3 9DU|
|Contact: Contact Person 44-1865-225-205 firstname.lastname@example.org|
|Principal Investigator:||Robert Davies, MD||Oxford University Hospitals NHS Trust|