Low Dose Ketamine Infusion for Analgesia in the Emergency Department (ED) to Reduce Side Effects: A Double Blind, Double Dummy Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Score
研究概览
简要总结
This will be an intent to treat prospective, double blind, double-dummy, randomized trial. Our primary objective is the reduction of side effects of sub dissociative dose ketamine given by slow intravenous (IV) infusion over 30 minutes vs. 15 minutes in the treatment of acute, severe pain in Emergency Department (ED) patients. The secondary objective will be to maintain adequate pain control (as defined by a Visual Analog Scale (VAS) score of ≤ 5cm) at 30 minutes for both groups.
详细描述
Previous research has shown that low dose ketamine (LDK) Intravenous push (IVP) (0.3mg/kg) to have equivalent pain reduction in moderate to severe acute pain in the Emergency Department (ED) when compared to standard of care of morphine intravenous push (IVP) (0.1mg/kg). Ketamine has been shown to produce side effects in these studies, including dizziness, feeling of unreality and mood changes, but no unexpected side effects or adverse events. Additional studies have compared IVP with slower infusion of low dose ketamine (LDK) and have shown a decrease in side effects while maintaining similar analgesic efficacy. This previous trial found increased feelings of unreality for the IVP group (difference of 37.5%) as well as increased rates of sedation.
In clinical practice, increasing the time/duration of the infusion has resulted in a decrease of reported side effects from patients while still maintaining analgesia. There have been no studies done to prove that there is a further reduction in side effects with a longer LDK infusion. The investigators believe that increasing the infusion time to greater than 15 minutes will reduce the frequency and intensity of expected side effects of ketamine felt by participants and allow for further use of ketamine as a non-opiate analgesic in the ED.
Overall aims of project:
- Reduce overall side effects of low dose ketamine when given over 30 minutes versus 15 minutes.
- Maintain adequate pain control, as defined by a Visual Analogue Scale (VAS) score of ≤5 cm at 30 minutes for both groups.
Hypothesis: Slow infusion of low dose ketamine (LDK) over 30 minutes will provide adequate pain control (as defined by VAS score of ≤5 cm), and reduce incidence and severity (by at least 20% or 1 point on SERSDA scale) of known side effects when compared to LDK given over 15 minutes in moderate to severe acute pain for patients presenting to 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or older
- •Primary complaint of acute moderate to severe pain on VAS/ numeric pain scale (a score of ≥5cm which corresponds to 50mm).
- •Pain described as abdominal, flank, back, musculoskeletal, or traumatic chest pain
- •Must be alert and oriented times three
- •Able to provide consent
排除标准
- •Breastfeeding
- •Altered mental status
- •Known or reported allergy, hypersensitivity or intolerance to ketamine
- •Unstable vital signs (systolic blood pressure <80 or >180mmHg, heart rate <50 or >150 beats per minute, and respiratory rate <10 or >30 breaths per minute)
- •History of unstable heart disease, such as arrhythmias, congestive heart failure, or coronary heart disease.
- •History of untreated or uncontrolled thyroid disease
- •Acute head or eye injury
- •Active or current use of alcohol or drugs
- •Known intracranial hypertension
- •Hepatic or renal insufficiency
- •Current active manic phase of bipolar disorder
- •Active delusions, hallucinations, or schizophrenia
- •Patients who have recent fentanyl use within 60 minutes or other analgesic use (opiates) within 4 hours of study enrollment (signing of consent)
- •Patients who have enrolled in the study during a previous ED encounter
- •Chronic use of opiates (i.e.: fentanyl patch, SR opiates)
研究组 & 干预措施
Ketamine 30 Minutes
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
干预措施: Ketamine (Drug)
Ketamine 15 Minutes
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
干预措施: Ketamine (Drug)
结局指标
主要结局
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Score
时间窗: 30 minutes
Overall side effects as measured by the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). SERDSA measures severity of nine adverse effects based on a 5-point scale from "0" (no adverse effect) to "4" (very bothersome effect).
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Composite Score
时间窗: 30 minutes
The Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) is a clinician administered tool used to evaluate acute side effects associated with ketamine infusion. The composite scale is a measure of the effects including fatigue, dizziness, headache, feeling of unreality, hearing, vision, or mood changes, generalized discomfort, and hallucinations. The SERSDA composite score is the mean overall score of nine adverse events on a scale of 0 (no adverse effect) to 36 (very bothersome effect).
次要结局
- Visual Analog Scale (VAS) Score(30 minutes)
- Richmond Agitation-Sedation Scale(30 Minutes)