Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in reported pain score at 15 minutes, 30 minutes, and hourly for 6 hrs or until discharge
研究概览
简要总结
This study aims to address both the management and evaluation of pain. The primary aim of this study is to determine the efficacy of low dose ketamine in adults with moderate to severe pain in the emergency department as compared with parenteral opioids alone. Another aim is to examine the safety of low dose ketamine compared to opioids alone.
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 and assessment of pain in the Emergency Department (ED) can be challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, inadequate analgesia is often a problem when opioids alone are relied on for pain control. In the peri-operative setting ketamine has been used as an adjunct to opioids for acute pain. Ketamine may play a role in maximizing analgesia in the ED.
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
- •English speaking
- •Adults age 18-65
- •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
- •ASA (American Society of Anesthesiologists) class I or II
排除标准
- •Previously enrolled in the study
- •Neurologic, respiratory, or hemodynamic compromise
- •GCS (Glasgow Coma Scale) <15
- •Pox <94%, RR <10, or RR >22
- •SBP <90, SBP>180, or DBP >110
- •Discretion of treating physician
- •Pregnancy or breastfeeding
- •Known or suspected allergy to ketamine or morphine
- •Ketamine within 24 hours of presentation (prescription or illicit drugs)
- •Conscious sedation in ED (per treating physician), includes ketamine (for non-study purposes)
- •Known Renal (Cr>2.0) or Liver Failure
- •Unstable psychiatric disease (as per treating physician)
- •History of stroke
- •History of cardiac disease
- •Prior myocardial infarction; Angina (Stable or Unstable)
- •Cardiac stents or bypass surgery
研究组 & 干预措施
LDK1: Low dose Ketamine (0.15mg/kg)
Participants randomized to the first group, LDK1, will receive an intravenous injection of low dose ketamine (0.15mg/kg).
All participants, regardless of the group, will receive a dose of morphine(0.15mg/kg) at the same time the study drug is administered.
干预措施: Ketamine 0.15mg/kg (Drug)
LDK2: Low dose Ketamine (0.3mg/kg)
Participants randomized to the second group, LDK2, will receive an intravenous injection of low dose ketamine (0.3mg/kg).
All participants, regardless of the group, will receive a dose of morphine(0.15mg/kg) at the same time the study drug is administered.
干预措施: Ketamine 0.3mg/kg (Drug)
0.9% Normal Saline
This group will receive a placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)
干预措施: Placebo (Other)
结局指标
主要结局
Change in reported pain score at 15 minutes, 30 minutes, and hourly for 6 hrs or until discharge
时间窗: Between patient arrival and patient discharge
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 research assistants (RA) 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: a rating of 0 corresponds to "no pain at all," whereas a rating of 10 is the "worst pain imaginable." Baseline NPRS will be measured after randomization, but just before administration of ketamine or placebo injection and morphine (Baseline). Repeat measurements will be taken at 15 minutes, 30 minutes, and hourly following treatment with the study drug, for 6hrs or until the patient leaves the ED. The amount of rescue analgesia will be recorded at each time point. The ED course will also be reviewed post hoc by the RAs and physician investigators to confirm analgesia received. The main outcome measure will be the change in pain score over time.
次要结局
- Safety--Determine the incidence of adverse events associated with ketamine and morphine, versus morphine alone at 5 minutes, 30 minutes, and hourly up to 6 hours.(15 minutes, 30 minutes, hourly up to 6 hours)