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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN97241637 |
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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.
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| Name | Class |
|---|---|
| Medical Research Council CTU | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Diamorphine or Morphine by PCA and oral ibuprofen |
|
| 2 | Placebo Comparator | Diamorphine or Morphine by PCA and oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient controlled analgesia (PCA)diamorphine or morphine consumption | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North West London Hospitals NHS Trust | London | NW10 7NS | United Kingdom | |||
| Imperial College Healthcare NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27288381 | Derived | 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. |
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| Placebo |
| Drug |
Matching placebo three times daily for 4 days |
|
| Diamorphine or Morphine | Drug | Diamorphine or Morphine by PCA |
|
| London |
| W12 0HS |
| United Kingdom |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D003932 | Heroin |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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