A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
研究概览
简要总结
Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
详细描述
Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.
Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.
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
All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ages 18-59
- •Weight 45 - 115 kg
- •Acute abdominal, flank, back, musculoskeletal pain, or a headache
- •Onset of pain within 7 days
- •Pain score of 5 or more
- •Requiring intravenous analgesia
- •Hasn't been enrolled in this study previously
排除标准
- •Pregnancy
- •Breast-feeding
- •Altered mental status rendering the patient unable to consent to the study
- •Allergy to ketamine
- •Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150 beats/minute, and respiration rate <10 or >30 breaths/minute)
- •History of acute head or eye injury, seizure, intracranial hypertension
- •Chronic pain
- •Renal or hepatic insufficiency
- •Known alcohol or drug use disorder
- •Currently under influence of alcohol/opiates
- •Acute psychiatric illness
研究组 & 干预措施
0.15 mg/kg IV Ketamine
干预措施: Ketamine (Drug)
0.3 mg/kg IV Ketamine
干预措施: Ketamine (Drug)
结局指标
主要结局
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
时间窗: 30 minutes
Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
次要结局
- Number of Participants Who Need Additional Pain Medication at 30 Minutes(30 minutes)
- Change in Pain Score From Baseline to 60 Minutes(60 minutes)
- Number of Patients Who Need Rescue Medications at 60 Minutes(60 minutes)
- Adverse Effects at 30 Min(30 minutes)
- Change in Pain Score From Baseline to 15 Minutes(15 minutes)
研究者
Shannon Lovett
Associate Professor of Department of Emergency Medicine
Loyola University