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

Phase 4

Terminated

• Conditions: Sickle Cell Disease
• Interventions: Drug: Ibuprofen; Drug: Placebo; Drug: Diamorphine or Morphine

• Registration Number: NCT00880373
• Lead Sponsor: London North West Healthcare NHS Trust

Brief 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.

Study Timeline

• Study First Submitted: 2009-04-09
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Study Start: 2011-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-04
• Primary Completion: 2014-03
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Adult patients with SCD of any phenotype

Exclusion Criteria

• Patient has a history of allergic reaction to either diamorphine/morphine or ibuprofen
• Patient has contraindications to diamorphine/morphine or ibuprofen, e.g. peptic ulcer disease, non-steroidal anti-inflammatory drug (NSAID)-induced asthma
• Patient in a drug dependency programme
• Patient is on renal dialysis
• Stroke within the last 6 weeks
• Platelet count less than 50 x 10^9/l
• Patient is pregnant or breastfeeding
• Doctor unwilling to randomise the patient for other reasons
• Previous participation in the trial
• Patient receiving drug treatment with which opioids or NSAIDs are likely to interact significantly
• Stage 1 - 5 chronic kidney disease (ref Appendix 2), including urine protein: creatinine ratio of >50 (Because the ibuprofen dose is substantial it is felt that precautions should be taken to exclude those who have any signs of chronic kidney disease. One of the signs of kidney disease is "persistent proteinuria". Therefore, the patient who intermittently has proteinuria(which could be due to other reasons) could still participate.)
• Oxygen saturation by pulse oximetry <94%
• Participation in another clinical trial within the last month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ibuprofen	Diamorphine or Morphine by PCA and oral ibuprofen
1	Diamorphine or Morphine	Diamorphine or Morphine by PCA and oral ibuprofen
2	Placebo	Diamorphine or Morphine by PCA and oral placebo
2	Diamorphine or Morphine	Diamorphine or Morphine by PCA and oral placebo

Primary Outcome Measures

Name	Time	Method
Patient controlled analgesia (PCA)diamorphine or morphine consumption	4 days

Secondary Outcome Measures

Name	Time	Method
Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale	4 days

Trial Locations

Locations (2)

North West London Hospitals NHS Trust; 🇬🇧 London, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom