Comparison of Ketamine 0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg Intravenous Doses for Acute Pain in the Emergency Department: A Prospective, Randomized, Double-blind, Active-controlled, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2 mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also examine the frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory analysis based on the need for rescue analgesia within two hours of ketamine administration, adequate pain relief, previous opioid tolerance, and age (adults < 65 years old and > 65 years old).
详细描述
A literature review was performed that searched for randomized clinical trials involving ketamine IV boluses for acute pain in the Emergency Department. Studies involving continuous infusions or intranasal routes of ketamine administration were not included. Thirteen randomized clinical trials were identified meeting this criteria. None of these trials directly compared ketamine doses within the 0.1-0.3 mg/kg range for pain score reduction and adverse events. Many of these trials concluded with the recommendation that further studies were needed to evaluate the optimal dosing of ketamine for acute pain and determine which populations are most ideal for its use. This study will be the first to evaluate ketamine for acute pain in the emergency department at standard of care doses (0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg IV) to determine which dose correlates with the most efficacy and safety.
This study will include the following procedures:
- Patient consent, screening, and enrollment will be performed by the treating resident or attending who will remain blinded
- Patient will be assigned a subject number
- Treating resident or attending will notify the ED pharmacist that a patient has been enrolled in the trial
- ED pharmacist will notify the IV room and place the study drug order
- Either the ED pharmacist or a pharmacy supervisor will randomize the subject based on the predetermined randomization list
- Study drug will be prepared as 0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg IV dose in a 100 mL solution of dextrose 5% or sodium chloride 0.9%
- ED pharmacist will promptly deliver the study drug to the ED
- Baseline vital signs will be assessed prior to starting the study drug infusion
- Study drug will be administered via IV infusion over 20 minutes
- Treating resident or attending will reassess the patient at 15 minutes from the end of infusion, at 30 minutes from the end of infusion, and then every 30 minutes for up to 120 minutes or until discharge, whichever is sooner
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)
盲法说明
Double-blinded study (only the pharmacist supervisor that has no other involvement with the study will know the dose)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute pain (including acute on chronic pain)
- •Pain score of moderate to severe (> 4/10) on the Numerical Rating Scale
- •Provider determines the patient requires intravenous ketamine for analgesia
排除标准
- •History of hypersensitivity to ketamine
- •Altered mental status
- •Psychiatric illness
- •Known history of renal or hepatic insufficiency
- •Acute head or eye injury
- •Suspected intracranial hypertension or mass
- •Headache as the chief complaint
- •Alcohol or drug abuse
- •Received an analgesic within the last four hours
- •History of congestive heart failure
- •History of aortic or brain aneurysm
- •Active Chest Pain
- •Porphyria
- •Active methadone treatment
- •Pregnant or breastfeeding
- •Signs of respiratory, hemodynamic, or neurologic compromise
- •Systolic blood pressure < 90 mmHg or > 180 mmHg
- •Heart rate < 50 beats per minute or > 150 beats per minute
- •Respiratory rate < 10 breaths per minute or > 30 breaths per minute
- •Glasgow Coma Score < 15
- •Previously received ketamine < 0.3 mg/kg IV for acute pain in the emergency department
研究组 & 干预措施
Arm 1: 0.1 mg/kg ketamine
0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
干预措施: Ketamine Injectable Product (Drug)
Arm 1: 0.2 mg/kg ketamine
0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
干预措施: Ketamine Injectable Product (Drug)
Arm 1: 0.3 mg/kg ketamine
0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
干预措施: Ketamine Injectable Product (Drug)
结局指标
主要结局
Pain Score
时间窗: Within 2 hours post infusion completion
Pain score using Numerical Rating Scale (NRS) post ketamine infusion. The Numerical Rating Scale (NRS) ranges from 0-to-10 with 0 being no pain and lower numbers representing less pain, so in this case lower numbers will represent better outcomes. Pain scores were reported at baseline and then at 15 min/30 min/60 min/90 min and 120 minutes post-infusion.
次要结局
- Adverse Events(Within 2 hours post infusion completion)