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

NCT00880373 | Terminated Phase 4 DMC

• 2 other identifiers: HTA 07/48/01ISRCTN97241637
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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).

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Pain; Ibuprofen; Morphine; Diamorphine; Patient Controlled Analgesia

Outcome Measures

Primary Outcomes (1)

• Patient controlled analgesia (PCA)diamorphine or morphine consumption

  4 days

Secondary Outcomes (1)

• Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale

  4 days

Study Arms (2)

1

ACTIVE COMPARATOR

Diamorphine or Morphine by PCA and oral ibuprofen

Drug: Ibuprofen; Drug: Diamorphine or Morphine

2

PLACEBO COMPARATOR

Diamorphine or Morphine by PCA and oral placebo

Drug: Placebo; Drug: Diamorphine or Morphine

Interventions

Ibuprofen DRUG

Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days

1

Placebo DRUG

Matching placebo three times daily for 4 days

2

Diamorphine or Morphine DRUG

Diamorphine or Morphine by PCA

1; 2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with SCD of any phenotype

You may not qualify if:

• 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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead
• Medical Research Council CTU: collaborator

Study Sites (2)

North West London Hospitals NHS Trust

London, NW10 7NS, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27288381 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Interventions

Ibuprofen; Heroin; Morphine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Kofi A Anie, PhD

  London North West Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

• Gavin Cho, MD

  London North West Healthcare NHS Trust

  STUDY CHAIR

• Mark Layton, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Sarah Meredith, MD

  MRC Clinical Trials Unit

  STUDY DIRECTOR

• Caroline Dore, BSc

  MRC Clinical Trials Unit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 13, 2009
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

GB (2)