Sickle Cell Disease
Conditions
Keywords
Sickle Cell Disease, Pain, Ibuprofen, Morphine, Diamorphine, Patient Controlled Analgesia
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.
Interventions
DRUGDiamorphine or Morphine
Diamorphine or Morphine by PCA
DRUGIbuprofen
Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days
DRUGPlacebo
Matching placebo three times daily for 4 days
Sponsors
Medical Research Council CTU
London North West Healthcare NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient controlled analgesia (PCA)diamorphine or morphine consumption | 4 days |
Secondary
| Measure | Time frame |
|---|---|
| Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale | 4 days |
Countries
United Kingdom
Outcome results
None listed