Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RADCLIFFE-TIME1 | |||
| ISRCTN33288337 | |||
| EUDRACT 2006-005226-31 | |||
| EU-20829 | |||
| UKCRN 4035 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibuprofen | Drug | |||
| morphine sulfate | Drug | |||
| management of therapy complications | Procedure | |||
| pleurodesis | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following:
No primary lymphoma or small cell lung carcinoma
All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 2 weeks since prior and no concurrent corticosteroid therapy
No concurrent warfarin therapy
No other concurrent analgesics
No concurrent enrollment on another clinical study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Davies, MD | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Radcliffe Hospital | Recruiting | Oxford | England | 0X3 9DU | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D009020 | Morphine |
| D018700 | Pleurodesis |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |