Status:
UNKNOWN
Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
Lead Sponsor:
Oxford University Hospitals NHS Trust
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 siz...
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 su...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00644319
Start Date
March 1 2007
Last Update
July 8 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU