Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Pain reduction after 10 minutes assessed on numeric rating scale, NRS
研究概览
简要总结
The KetMo study is an investigator-initiated, randomized, parallel group, double blinded trial investigating if ketamine as an adjunct to morphine improves pain treatment in the ED.
Patients in pain (assessed on NRS, 5 or more) will be randomized to low-dose ketamine or placebo as an adjunct to morphine. Patients with or without prior use of opioids will be randomized separately.
The primary outcome will be pain reduction, assessed on NRS, after 10 minutes. Secondary outcomes include pain reduction until 120 minutes after injection of study medicine, need for rescue opioid, side effects and patient- and provider satisfaction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency Department admission
- •Age ≥ 18 years
- •Stable vital signs defined as systolic blood pressure ≥ 90 mmHg, heart rate between 60 and 150 per minute, respiratory rate between 8 and 26 per minute, oxygen saturation greater than or equal to 92%
排除标准
- •Initial management by trauma-team
- •Systolic blood pressure ≥ 180mmHg, severe untreated arrhythmia, unstable angina, recent myocardial infarction (< 30 days), severe heart-failure (Ejection fraction < 40 %)
- •Symptoms of untreated hyperthyroidism
- •Cirrhosis with ascites
- •Known/suspected pregnancy or breastfeeding
- •Patients for whom consent is not obtainable or psychiatric forced treatment.
- •Previously enrolled in the trial
- •Psychiatric illness prior to admission defined as prior psychosis/schizophrenia
- •Untreated diagnosed glaucoma
- •Known hypersensitivity to ketamine or to any excipient or prior use of ketamine with a negative experience (i.e. hallucinations)
- •Patient clearly influenced by drugs or alcohol
研究组 & 干预措施
Placebo
Two 1 ml syringes with saline will be prepared and study drug will be administered as intravenous dose, same volume as if Esketamine. The placebo drug will be administered after an intravenous morphine dose.
干预措施: Placebo (saline) (Drug)
Intervention, low-dose ketamine
Two 1 ml syringes with Esketamine (5 mg/ml) will be prepared and study drug will be administered as intravenous bolus dose, 0,1 mg/kg. The study drug will be administered after an intravenous morphine dose.
干预措施: low dose ketamine (Drug)
结局指标
主要结局
Pain reduction after 10 minutes assessed on numeric rating scale, NRS
时间窗: 10 minutes
Numeric Rating Scale, 0-10
次要结局
- Pain intensity assessed on numeric rating scale, NRS(120 minutes)
- Need for rescue opioid(120 minutes)
- Comparison af pain reduction ( prior use of opioid vs no prior use of opioid(120 minutes)
- Side effects(120 minutes)
- Patient satisfaction(120 minutes)
- Provider satisfaction(120 minutes)
- Patient Rated Pain Relief(Patient are asked at timepoint 10 and timepoint 120)