NCT00880373

Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine

An Evaluation of the Effectiveness of Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease: a Double-blind, Placebo-controlled Randomised Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: London North West Healthcare NHS Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD).

Detailed description

Pain from vaso-occlusion in sickle cell disease (SCD) is persistent, and its management continues to pose a challenge to practitioners. Opioids are recommended for the treatment of severe acute SCD pain, and have been used successfully within the hospital setting. Non-steroidal Anti-Inflammatory Drugs (NSAIDs) are recommended for acute SCD pain, however there is no clear evidence for the effectiveness of oral NSAIDs in combination with parenteral opioids in adults with SCD.Data from acute pain research suggests that oral ibuprofen is one of the best NSAIDs for combination treatment with morphine via PCA. This is a randomised controlled trail to evaluate the effectiveness of oral ibuprofen plus intravenous Diamorphine or morphine via PCA. The results will provide the evidence needed to recommend whether or not ibuprofen should be used in acute SCD pain.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Ibuprofen	Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days
DRUG	Placebo	Matching placebo three times daily for 4 days
DRUG	Diamorphine or Morphine	Diamorphine or Morphine by PCA

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-03-01
• Completion: 2014-08-01
• First posted: 2009-04-13
• Last updated: 2012-12-04

Locations

2 sites across 1 country: United Kingdom