Ibuprofen and Morphine for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine
Information source: North West London Hospitals NHS Trust
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Disease
Intervention: Ibuprofen (Drug); Ibuprofen Placebo (Drug); Morphine (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: North West London Hospitals NHS Trust Official(s) and/or principal investigator(s):
Kofi A Anie, PhD, Principal Investigator, Affiliation: North West London Hospitals NHS Trust
Gavin Cho, MD, Principal Investigator, Affiliation: North West London Hospitals 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
Overall contact:
Kofi A Anie, PhD, Phone: +44 (0)20 8453 2050, Email: Kofi.Anie@nwlh.nhs.uk
Summary
The use of oral ibuprofen combined with morphine 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 Morphine for Acute Pain in Sickle Cell Disease: a Double-Blind, Placebo-Controlled Randomised Trial
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Patient controlled analgesia (PCA) 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. Also, morphine via patient controlled analgesia (PCA)
results in adequate pain relief. 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 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 morphine or ibuprofen
- Patient has contraindications to 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
Locations and Contacts
Kofi A Anie, PhD, Phone: +44 (0)20 8453 2050, Email: Kofi.Anie@nwlh.nhs.uk
North West London Hospitals NHS Trust, London NW10 7NS, United Kingdom
Imperial College Healthcare NHS Trust, London W12 0HS, United Kingdom
Additional Information
Starting date: September 2009
Ending date: August 2013
Last updated: April 10, 2009
|
