Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
An evaluation of the effectiveness of ibuprofen and morphine for acute pain in sickle cell disease |
Project ref: |
07/48/01 |
Cost: |
£715,013 |
Chief Investigator : |
Dr Kofi Arhu Anie, Clinical Psychologist, Haematology and Sickle Cell Centre, North West London Hospitals NHS Trust |
Start Date: |
September 2009 |
Estimated date of publication in HTA journal series: |
Late 2014. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Sickle cell disease is an inherited disorder of red blood cells, affects over 12,000 people in the UK, about 70% in London. 'Sickle' red blood cells change shape on giving up oxygen, hence the name, and can lose water (dehydrate). The sickle cells block small blood vessels, this causes what is called pain crisis and long term damage to organs. Severe pain crisis usually leads to hospital admission, and opioids such as morphine are recommended for treatment. However, morphine has some side effects including nausea, constipation, itching, and mood changes. Also, morphine can precipitate other complications including a condition called sickle acute chest syndrome where there is infarction (injury) in the chest. Better ways to manage sickle cell pain are required. Hardly any research has been done in the UK to see how effective different painkillers are in the management of sickle cell disease. Some studies have been done in other countries with different types of opioids, and other groups of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs). One recent study also showed that treating sickle cell pain with morphine through 'patient controlled analgesia' (PCA) is preferred. In our study, we propose to study a combination of ibuprofen (an effective NSAID) and morphine through PCA in adults with sickle cell pain crisis and admitted to hospital, with a view that this would lead to a reduction in the amount of morphine used over 4 days, better pain relief, improved mood, less side effects, and increased patient satisfaction. This study would be developed with input from patients with sickle cell disease, the Sickle Cell Society, and carried out jointly with the MRC Clinical Trials Unit, one of the leading units for medical research in the UK, and a group of hospitals in North West London, including Central Middlesex and Hammersmith Hospitals with a track record of research in sickle cell disease. We hope to show that taking ibuprofen in addition to morphine through a PCA pump leads to substantial reduction in the use of morphine and related side effects for sickle cell pain treated in hospital. If this is the case, we anticipate that there would also be an overall improvement in patients' experience, and perhaps a reduction in NHS costs related to frequent hospital admissions. |
Project Abstract: |
Sickle cell disease (SCD) is an inherited disorder of red blood cells, which affects over 12,000 people in the UK. Pain associated with vaso-occlusion in (SCD) is persistent, and its management continues to pose a challenge to both clinicians and patients. Opioids are recommended for the treatment of severe acute SCD pain, and have been used successfully within the hospital setting. A Cochrane Systematic Review (Dunlop & Bennett, 2006) suggests that non-steroidal anti-inflammatory drugs (NSAIDs) should also be considered 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, a randomised controlled trial in SCD showed that morphine via patient controlled analgesia (PCA) results in adequate pain relief with lower consumption when compared with continuous infusion (van Beers et al, 2007). Data from acute pain research suggests that oral ibuprofen is one of the best NSAIDs (Barden et al, 2004) for combination treatment with morphine via PCA. This study is a randomised controlled trial to evaluate the effectiveness of oral ibuprofen plus intravenous morphine via PCA. The results will provide the evidence needed to recommend whether or not ibuprofen should be used as a supplementary NSAID for the management of acute sickle cell pain. 1. Barden J, Edwards J, Moore RA, McQuay HJ. Single dose oral diclofenac for postoperative pain. Cochrane Database Syst Rev. 2004 (2): CD004768. 2. Dunlop RJ, Bennett KC. Pain management for sickle cell disease. Cochrane Database Syst Rev. 2006 (2): CD003350. 3. van Beers EJ, van Tuijn CF, Nieuwkerk PT, Friederich PW, Vranken JH, Biemond BJ. Patient-controlled analgesia versus continuous infusion of morphine during vaso-occlusive crisis in sickle cell disease, a randomized controlled trial. Am J Hematol. 2007. |
ISRCTN* number: | ISRCTN 97241637 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN97241637 |
Project Protocol: |
Project protocol (pdf format, 138 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1782 |
News feeds