Ibuprofen and Morphine for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine - Full Text View

Sponsor:	North West London Hospitals NHS Trust
Information provided by:	North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00880373

Purpose

The use of oral ibuprofen combined with Diamorphine or morphine 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 IV

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 Morphine for Acute Pain in Sickle Cell Disease: a Double-blind, Placebo-controlled Randomised Trial

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Sickle Cell Anemia

Drug Information available for: Ibuprofen Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

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 for each active drug, 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. Also, diamorphine or morphine via patient controlled analgesia (PCA) results in adequate pain relief. 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

Contacts and Locations

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

Contacts

Contact: Kofi A Anie, PhD	+44 (0)20 8453 2050	Kofi.Anie@nwlh.nhs.uk
Contact: Gavin Cho, MD	+44 (0)20 8453 2112	Gavin.Cho@nwlh.nhs.uk

Locations

United Kingdom
North West London Hospitals NHS Trust	Recruiting
London, United Kingdom, NW10 7NS
Contact: Kofi A Anie, PhD +44 (0)20 8453 2050 Kofi.Anie@nwlh.nhs.uk
Contact: Gavin Cho, MD +44 (0)20 8453 2112 Gavin.Cho@nwlh.nhs.uk
Principal Investigator: Kofi A Anie, PhD
Principal Investigator: Gavin Cho, MD
Imperial College Healthcare NHS Trust	Not yet recruiting
London, United Kingdom, W12 0HS
Contact: Mark Layton, MD 020 8383 2173 m.layton@imperial.ac.uk
Principal Investigator: Mark Layton, MD

Sponsors and Collaborators

North West London Hospitals NHS Trust

Investigators

Principal Investigator:	Kofi A Anie, PhD	North West London Hospitals NHS Trust
Principal Investigator:	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:	March 14, 2011
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
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Heroin
Morphine
Ibuprofen
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012