ibuprofen or morphine in treating pain in patients undergoing pleurodesis for malignant pleural effusion

Conditions: Metastatic Cancer

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.

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.

Eligibility 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

Keywords: malignant pleural effusion