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

This study has been terminated.
(The funding withdrawal and early termination of the trial is based upon lack of suitable recruitment figures in order to reach the required trial endpoints.)
Sponsor:
Collaborator:
Medical Research Council CTU
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00880373
First received: April 9, 2009
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Sickle Cell Disease
Drug: Ibuprofen
Drug: Placebo
Drug: Diamorphine or Morphine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by North West London Hospitals NHS Trust:

Primary Outcome Measures:
  • Patient controlled analgesia (PCA)diamorphine or morphine consumption [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: March 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Diamorphine or Morphine by PCA and oral ibuprofen
Drug: Ibuprofen
Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days
Drug: Diamorphine or Morphine
Diamorphine or Morphine by PCA
Placebo Comparator: 2
Diamorphine or Morphine by PCA and oral placebo
Drug: Placebo
Matching placebo three times daily for 4 days
Drug: Diamorphine or Morphine
Diamorphine or Morphine by PCA

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880373

Locations
United Kingdom
North West London Hospitals NHS Trust
London, United Kingdom, NW10 7NS
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
North West London Hospitals NHS Trust
Medical Research Council CTU
Investigators
Principal Investigator: Kofi A Anie, PhD North West London Hospitals NHS Trust
Study Chair: Gavin Cho, MD North West London Hospitals NHS Trust
Principal Investigator: Mark Layton, MD Imperial College London
Study Director: Sarah Meredith, MD MRC Clinical Trials Unit
Study Director: Caroline Dore, BSc MRC Clinical Trials Unit
  More Information

No publications provided

Responsible Party: Dr Kofi Anie, North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00880373     History of Changes
Other Study ID Numbers: HTA 07/48/01, ISRCTN97241637
Study First Received: April 9, 2009
Last Updated: December 3, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by North West London Hospitals NHS Trust:
Sickle Cell Disease
Pain
Ibuprofen
Morphine
Diamorphine
Patient Controlled Analgesia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Acute Pain
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Heroin
Ibuprofen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014