Clinical trial · Interventional
Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
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]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ibuprofen | Drug | Ibuprofen | ALIAS |
| management of therapy complications | Procedure | — | UNRESOLVED |
| morphine sulfate | Drug | — | UNRESOLVED |
| pleurodesis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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
- measure
- Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion, censored for survival)
Secondary outcomes (10)
- measure
- Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization
- measure
- Change in hemoglobin and white cell count from day 0 to day 3
- measure
- Change in renal function and liver function (i.e., ALT or AST, bilirubin, albumin, and alk phos) from day 0 to day 3
- measure
- Change in Inflammatory markers from day 0 and day 3 (e.g., CRP, WCC) from day 0 to day 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available