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

NCT00644319 | Unknown Phase 2

• 6 other identifiers: CDR0000590072RADCLIFFE-TIME1ISRCTN33288337EUDRACT 2006-005226-31EU-20829UKCRN 4035
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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 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

Metastatic Cancer

Keywords

malignant pleural effusion

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (10)

• 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

• 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

Interventions

ibuprofen DRUG

morphine sulfate DRUG

management of therapy complications PROCEDURE

pleurodesis PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Pleural Effusion, Malignant

Interventions

Ibuprofen; Morphine; Pleurodesis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Therapy; Therapeutics

Study Officials

• Robert Davies, MD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 26, 2008
• Study Start: March 1, 2007
• Primary Completion: September 1, 2009
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

GB (1)