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

London North West Healthcare NHS Trust

Status and phase

Terminated

Phase 4

Conditions

Sickle Cell Disease

Treatments

Drug: Diamorphine or Morphine

Drug: Ibuprofen

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00880373

ISRCTN97241637

HTA 07/48/01

Details and patient eligibility

About

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).

Full 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.

Enrollment

320 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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