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
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