Benefit of the Association of Low Doses of Ketamine With Intravenous Morphine in the Treatment of Acute Severe Pain in Emergency Department
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Efficacy of analgesia: To assess the primary outcome of pain relief, we used patient-reported pain scores. We consider the pain decreasing of at least 50% of pain score and the summed pain-intensity difference (SPID) over 2 hours
研究概览
简要总结
This study aims to determine the efficacy and safety of low dose ketamine in association with IV morphine in the management of acute moderate to severe pain in emergency department.
The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.
详细描述
Management of pain in the Emergency Department is challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, the use of opioids alone for pain control is often associated with inadequate analgesia and increased adverse events.
Low-dose ketamine has been shown to improve pain perception and produce an opioid-sparing effect when given perioperatively.
Its use in the ED may probably play a role in maximizing analgesia.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and give informed consent
- •Comfortable with the experimental protocol as outlined to them by the research team
- •Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
- •Acute pain, pain duration < 7days
- •Deemed by treating ED attending physician to require IV opioid analgesia
排除标准
- •Neurologic, respiratory, or hemodynamic compromise
- •Pregnancy or breastfeeding
- •Known or suspected allergy to ketamine or morphine
- •Known Renal (Cr>2.0) or Liver Failure
- •Unstable psychiatric disease (as per treating physician)
- •History of stroke
- •History of cardiac disease or coronary artery disease
- •History of chronic respiratory disease
研究组 & 干预措施
Morphine and Placebo
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg)
干预措施: Placebos (Drug)
Morphine and Placebo
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg)
干预措施: Morphine (Drug)
Morphine and Ketamine 0.15
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg
干预措施: Ketamine (Drug)
Morphine and Ketamine 0.15
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg
干预措施: Morphine (Drug)
Morphine and Ketamine 0.3
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg
干预措施: Ketamine (Drug)
Morphine and Ketamine 0.3
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg
干预措施: Morphine (Drug)
结局指标
主要结局
Efficacy of analgesia: To assess the primary outcome of pain relief, we used patient-reported pain scores. We consider the pain decreasing of at least 50% of pain score and the summed pain-intensity difference (SPID) over 2 hours
时间窗: Two hours after starting protocol
At baseline, to assess our primary aim, efficacy of pain control, we will use patient reported pain scores and amount of rescue analgesia (parenteral morphine) received. Trained residents will ask participants to report their pains scores using a numerical pain rating scale (NPRS). The NPRS used will be a 0 to 10 rating scale. Baseline NPRS will be measured after randomization, but just before administration of morphine. Change in reported pain score during the protocol will be analysed. The SPID was calculated using the pain-intensity difference (PID) at each of these study time points. The PID for a given time point is equal to the baseline NPRS minus the subsequent NPRS at each study time point. SPID is the summation of the PID at each of the study time points, weighted using the amount of time since the prior assessment
次要结局
- The occurrence of adverse events(Two hours after starting protocol)
- Amount of rescue analgesia received(Two hours after starting protocol)
- The total dose of morphine administered(Two hours after starting protocol)
- Total patient-perceived pain relief(Two hours after starting protocol)
- Time to rescue analgesia(Two hours after starting protocol)
研究者
HAJER KRAIEM
M.D
Faculty of Medicine, Sousse