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临床试验/NCT02916927
NCT02916927已完成4 期

Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department: A Prospective, Randomized, Double-blind Placebo Controlled Trial

Alameda Health System1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
62
试验地点
1
主要终点
Side Effects

研究概览

简要总结

Objective: The purpose of this study is to determine if administering ketamine as an intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse drug reactions without attenuating its analgesic effects.

Study design: prospective, randomized, controlled, double-blind trial.

详细描述

Objective: The purpose of this randomized, controlled, double-blind trial is to evaluate if sub-dissociated dose ketamine given as an infusion versus an intravenous (IV) push over 1 minute has fewer and/or less severe adverse drug reactions and provides equivalent analgesia for patients with moderate to severe pain in the emergency department (ED).

Study design: Prospective, randomized, controlled, double-blind trial

Participants: Research assistants will recruit patients ≥18 years old with moderate to severe pain (NRS≥5) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed based on prior data which suggests that 60% of IV push arm and 20 % of infusion arm will have adverse drug reactions. investigators assume an alpha of 0.05 and a power of 0.8, which results in 56 patients needing to be enrolled.

Intervention: After a trained research assistant obtains written informed consent, pharmacists will randomize the participants to the IV push or IV infusion arm of the study. All patients will be placed on a cardiac monitor. All patients will receive and IV push over 1 minute and a 100 mL normal saline minibag over 15 minutes.

In the IV push arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 10 mL syringe and a 100 mL normal saline minibag. The nurse will start the minibag of normal saline and then administer the IV push of ketamine over 1 minute.

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

入选标准

  • Pain NRS ≥5
  • Anticipated stay in ED ≥1 hour

排除标准

  • Pregnant or breast feeding
  • Vital sign abnormalities (SBP <90, SBP > 180, HR < 50, HR > 150, RR <10, RR > 30, weight <45 kg, weight > 115 kg)
  • Arrhythmias
  • Altered mental status (active psychosis/delirium)
  • Administration of opioid pain medication in previous 1 hour
  • history of acute head or ocular trauma
  • presence of known intracranial mass or vascular lesion

研究组 & 干预措施

Ketamine IV infusion

Experimental

Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.

干预措施: Ketamine IV Infusion (Drug)

Ketamine IV push

Active Comparator

Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.

干预措施: Ketamine IV push (Drug)

结局指标

主要结局

Side Effects

时间窗: 0 - 60 minutes

The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.

次要结局

  • How Bothersome Are the Side Effects?(5, 10, 15, 20, 30, 45, 60 minutes)
  • Reduction in Pain on Numeric Rating Scale.(5, 10 , 15, 20, 30, 45, 60 minutes)
  • Side Effect Severity(5, 10, 15, 20, 30, 45, 60 minutes)
  • Side Effects(5, 10, 15, 20, 30, 45, 60 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eben Clattenburg

Investigator

Alameda Health System

研究点 (1)

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