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

NCT ID: NCT00644319

Last Updated: 2009-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

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.

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 sulfate in patients with malignant pleural effusion.
• To evaluate whether chest drain size influences the amount of post-pleurodesis pain.

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.

• Arm I: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
• Arm II: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
• Arm III: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.
• Arm IV: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.

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.

Conditions

Metastatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

ibuprofen

Intervention Type: DRUG

morphine sulfate

Intervention Type: DRUG

management of therapy complications

Intervention Type: PROCEDURE

pleurodesis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Principal Investigators

Robert Davies, MD

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

Oxford Radcliffe Hospital

Oxford, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Contact Person

Role: primary

robert.davies@ndm.ox.ac.uk

44-1865-225-205

Other Identifiers

RADCLIFFE-TIME1

Identifier Type: -

Identifier Source: secondary_id

ISRCTN33288337

Identifier Type: -

Identifier Source: secondary_id

EUDRACT 2006-005226-31

Identifier Type: -

Identifier Source: secondary_id

EU-20829

Identifier Type: -

Identifier Source: secondary_id

UKCRN 4035

Identifier Type: -

Identifier Source: secondary_id

CDR0000590072

Identifier Type: -

Identifier Source: org_study_id