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30 July 2010
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| [ Print-friendly version ] |
| Ibuprofen and morphine for acute pain in sickle cell disease |
| ISRCTN | ISRCTN97241637 |
| ClinicalTrials.gov identifier | NCT00880373 |
| Public title | Ibuprofen and morphine for acute pain in sickle cell disease |
| Scientific title | An evaluation of the effectiveness of ibuprofen and morphine for acute pain in sickle cell disease: a double-blind, placebo-controlled randomised trial |
| Acronym | SWIM (Sickle With Ibuprofen and Morphine) Trial |
| Serial number at source | HTA 07/48/01 |
| Study hypothesis |
The use of oral ibuprofen combined with morphine administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD).
Protocol can be found at: http://www.hta.ac.uk/protocols/200700480001.pdf More details can be found at: http://www.hta.ac.uk/1782 |
| Ethics approval | London Research Ethics Committee approved on the 27th February 2009 (ref: 08/H0718/79) |
| Study design | Double-blind, placebo-controlled randomised trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Sickle cell disease |
| Participants - inclusion criteria | Adult patients with SCD of any phenotype and gender aged 16 years and over. |
| Participants - exclusion criteria |
1. Patient has a history of allergic reaction to either morphine or ibuprofen
2. Patient has contraindications to morphine or ibuprofen, e.g. peptic ulcer disease, non-steroidal anti-inflammatory drug (NSAID)-induced asthma 3. Patient in a drug dependency programme 4. Patient is on renal dialysis 5. Stroke within the last 6 weeks 6. Platelet count less than 50 x 10^9/l 7. Patient is pregnant or breastfeeding 8. Doctor unwilling to randomise the patient for other reasons 9. Previous participation in the trial |
| Anticipated start date | 01/09/2009 |
| Anticipated end date | 31/08/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 320 |
| Interventions |
Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days. There will be a matching placebo for each active drug. Participants will be randomly allocated to one of two treatment groups:
1. Morphine by PCA and oral ibuprofen 2. Morphine by PCA and oral placebo Follow-up is at 1 week and 4 weeks post-discharge for both treatment groups. |
| Primary outcome measure(s) | PCA morphine consumption over 4 days |
| Secondary outcome measure(s) |
1. Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale within 4 days (based on assessments of patients attending Central Middlesex Hospital)
2. Mood - measured on the Hospital Anxiety and Depression Scale (HADS) 3. Adverse opioid effects - including nausea, constipation, itching, and central nervous system effects 4. Other sickle cell complications - including neurological events, and acute chest syndrome 5. Use of blood transfusions - treatment for complications during or post-discharge study period of 4 weeks 6. Health service utilisation cost - length of hospital admission, and re-admission in 7 - 14 days 7. Quality of life and utility - measured on the EuroQol (EQ-5D) 8. Patient satisfaction - patient experience at discharge |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Kofi Anie |
| Address |
Haematology and Sickle Cell Centre
North West London Hospitals NHS Trust Central Middlesex Hospital Acton Lane |
| City/town | London |
| Zip/Postcode | NW10 7NS |
| Country | United Kingdom |
| Tel | +44 (0)20 8453 2050 |
| Fax | +44 (0)20 8453 2051 |
| Kofi.Anie@nwlh.nhs.uk | |
| Sponsor | North West London Hospitals NHS Trust (UK) |
| Address |
Research and Development
Northwick Park Hospital Watford Road Harrow |
| City/town | Middlesex |
| Zip/Postcode | HA1 3UJ |
| Country | United Kingdom |
| Tel | +44 (0)20 8869 2011 |
| Fax | +44 (0)20 8869 5081 |
| Research@nwlh.nhs.uk | |
| Sponsor website: | http://www.nwlh.nhs.uk |
| Date applied | 03/04/2009 |
| Last edited | 30/06/2009 |
| Date ISRCTN assigned | 08/04/2009 |
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