Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Post Traumatic Acute Pain in the Emergency Department
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- VAS decrease of more than 50% comparing to initial value at 30 minutes following analgesia administration
研究概览
简要总结
Pain is the most common complaint for emergency department (ED) visit. Intranasal ketamine has been shown to provide rapid, well-tolerated, effective analgesia to emergency department (ED) patients with acute pain. few trials have studied ketamine infusion subcutaneously for pain management in trauma patients.
详细描述
Materials and methods :
Study design It is a randomized, prospective, double blind, controlled, multicentric trial.
Study setting and selection of participants :
The trial is conducted in three community teaching hospitals :
- Emergency department, fattouma bourgiba university hospital, monastir, tunisia.
- Emergency department, sahloul university hospital, sousse, tunisia.
- Emergency department, farhat hached university hospital, sousse, tunisia.
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, Outcomes Assessor)
盲法说明
After initial medical evaluation, every patient who meet the inclusion criteria, will receive randomly either subcutaneous or intanasal dose of ketamine as detailed above according to the predetermined randomization. To ensure a double-blind administration of ketamine ; patients enrolled in the intranasal ketamine group will receive concomitantly 1ml of normal saline solution subcutaneously, and patients enrolled in the subcutaneous ketamine group will receive concomitantly a spray of normal saline solution in each nostril. None of the treating physician or nurses are aware about the medication received.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients who presented to the ED with acute limb trauma pain with a visual analgesic scale (VAS) of 5 or more on a standard 11 point (0-10).
- •Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.
排除标准
- •Pregnancy/Breastfeeding
- •altered mental status (GCS<15)
- •Allergy to ketamine or morphine
- •Weight less than 40 kg or greater than 100kg
- •Unstable vital signs (systolic blood pressure <90 or > 180mmHg, pulse rate<50 or >150bpm, and respiration rate <10 or >30 breath/min)
- •Medical history of acute head or eye injury
- •Medical history of seizure
- •Medical history of intracranial hypertension,
- •Medical history of chronic pain,
- •Medical history of severe renal or hepatic insufficiency.
- •Medical history of glaucoma
- •Alcohol or drug abuse
- •Psychiatric illness,
- •Recent (4 hours before) analgesic agent use.
研究组 & 干预措施
Intranasal ketamine
Ketamine solution 250 mg/5ml was used. It was applied intranasally using a nasal spray pump whereeach spray delivered approximately 0.4 ml of solution corresponding to 20 mg of ketamine. After initial evaluation, each patient having the inclusion criteria receives one pulverisation (0.4 ml) per nostril of ketamine corresponding to a total dose of 20 mg of ketamine. Ketamine dosing was based on previous reports of intranasal ketamine use in ED patients, doses ranged from 0.45mg/kg to 1.25mg/kg (9).
干预措施: Ketamine (Drug)
subcutanous ketamine
Ketamine dosing by subcutanous route was based on previous reports use for post operative pain management. . The results of these reports revealed that low-dose ketamine 20-60 mg (0.5mg/kg for patients weighing 40-120 kg) showed an over all decrease in either the amount of opioid used or the amount of pain experienced (10, 11).For our study, we decided to chose a dose of 20mg of ketamine for all patients administered via 1ml insulin syringe once subcutaneously.
干预措施: Ketamine (Drug)
结局指标
主要结局
VAS decrease of more than 50% comparing to initial value at 30 minutes following analgesia administration
时间窗: 30 minutes
resolution of pain with decrease of VAS more than 50% comparing to initial value
rate of severe adverse events
时间窗: 120 minutes
occurence of severe adverse events
次要结局
- rate of rescue analgesia 1 doses of morphine required to reach efficient analgesia(30 minutes)
- rate of rescue analgesia 2 doses of morphine required to reach efficient analgesia(120 minutes)
研究者
Pr. Semir Nouira
Monastir Emergency departement
University of Monastir