An Evaluation of the Effectiveness of Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease: a Double-blind, Placebo-controlled Randomised Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Patient controlled analgesia (PCA)diamorphine or morphine consumption
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with SCD of any phenotype
排除标准
- •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
研究组 & 干预措施
1
Diamorphine or Morphine by PCA and oral ibuprofen
干预措施: Ibuprofen (Drug)
1
Diamorphine or Morphine by PCA and oral ibuprofen
干预措施: Diamorphine or Morphine (Drug)
2
Diamorphine or Morphine by PCA and oral placebo
干预措施: Placebo (Drug)
2
Diamorphine or Morphine by PCA and oral placebo
干预措施: Diamorphine or Morphine (Drug)
结局指标
主要结局
Patient controlled analgesia (PCA)diamorphine or morphine consumption
时间窗: 4 days
次要结局
- Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale(4 days)