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

NCT ID: NCT00880373

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Sickle Cell Disease

Keywords

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Sickle Cell Disease Pain Ibuprofen Morphine Diamorphine Patient Controlled Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Diamorphine or Morphine by PCA and oral ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

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

Diamorphine or Morphine

Intervention Type DRUG

Diamorphine or Morphine by PCA

2

Diamorphine or Morphine by PCA and oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo three times daily for 4 days

Diamorphine or Morphine

Intervention Type DRUG

Diamorphine or Morphine by PCA

Interventions

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Ibuprofen

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

Intervention Type DRUG

Placebo

Matching placebo three times daily for 4 days

Intervention Type DRUG

Diamorphine or Morphine

Diamorphine or Morphine by PCA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council CTU

UNKNOWN

Sponsor Role collaborator

London North West Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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North West London Hospitals NHS Trust

Principal Investigators

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Kofi A Anie, PhD

Role: PRINCIPAL_INVESTIGATOR

London North West Healthcare NHS Trust

Gavin Cho, MD

Role: STUDY_CHAIR

London North West Healthcare NHS Trust

Mark Layton, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Sarah Meredith, MD

Role: STUDY_DIRECTOR

MRC Clinical Trials Unit

Caroline Dore, BSc

Role: STUDY_DIRECTOR

MRC Clinical Trials Unit

Locations

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North West London Hospitals NHS Trust

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27288381 (View on PubMed)

Other Identifiers

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ISRCTN97241637

Identifier Type: -

Identifier Source: secondary_id

HTA 07/48/01

Identifier Type: -

Identifier Source: org_study_id