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

Sickle Cell Disease Clinical Trial

— SWIM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00880373
• Other study ID #: HTA 07/48/01
• Secondary ID: ISRCTN97241637
• Status: Terminated
• Phase: Phase 4
• First received: April 9, 2009
• Last updated: December 3, 2012
• Start date: March 2011
• Est. completion date: August 2014

Study information

• Verified date: December 2012
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 320
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• Ibuprofen
Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days
• Placebo
Matching placebo three times daily for 4 days
• Diamorphine or Morphine
Diamorphine or Morphine by PCA

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	North West London Hospitals NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust	Medical Research Council CTU

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient controlled analgesia (PCA)diamorphine or morphine consumption		4 days	No
Secondary	Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale		4 days	No