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

Information source: London North West Healthcare NHS Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sickle Cell Disease

Intervention: Ibuprofen (Drug); Placebo (Drug); Diamorphine or Morphine (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: London North West Healthcare NHS Trust

Official(s) and/or principal investigator(s):
Kofi A Anie, PhD, Principal Investigator, Affiliation: London North West Healthcare NHS Trust
Gavin Cho, MD, Study Chair, Affiliation: London North West Healthcare NHS Trust
Mark Layton, MD, Principal Investigator, Affiliation: Imperial College London
Sarah Meredith, MD, Study Director, Affiliation: MRC Clinical Trials Unit
Caroline Dore, BSc, Study Director, Affiliation: MRC Clinical Trials Unit

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Patient controlled analgesia (PCA)diamorphine or morphine consumption

Secondary outcome: Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale

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.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Imperial College Healthcare NHS Trust, London W12 0HS, United Kingdom

North West London Hospitals NHS Trust, London NW10 7NS, United Kingdom

Additional Information

Starting date: March 2011
Last updated: December 3, 2012

Page last updated: August 23, 2015

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