Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford University Hospitals NHS Trust
• Treatments: Ibuprofen; Morphine

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