Clinical trial NCT00880373: Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Pain
Ibuprofen
Morphine
Diamorphine
Patient Controlled Analgesia
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Medical Research Council CTU
First posted: 2009-04-13
Enrollment: 320
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Patient controlled analgesia (PCA)diamorphine or morphine consumption
timeFrame: 4 days
Secondary outcomes:
measure: Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale
timeFrame: 4 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: North West London Hospitals NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: London North West Healthcare NHS Trust
name: Kofi A Anie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London North West Healthcare NHS Trust
name: Gavin Cho, MD
role: STUDY_CHAIR
affiliation: Imperial College London
name: Mark Layton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MRC Clinical Trials Unit
name: Sarah Meredith, MD
role: STUDY_DIRECTOR
affiliation: MRC Clinical Trials Unit
name: Caroline Dore, BSc
role: STUDY_DIRECTOR
References:
citation: Cho G, Anie KA, Buckton J, Kiilu P, Layton M, Alexander L, Hemmaway C, Sutton D, Amos C, Dore CJ, Kahan B, Meredith S. SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt. BMJ Open. 2016 Jun 9;6(6):e011276. doi: 10.1136/bmjopen-2016-011276.