Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Visual analogue score
研究概览
简要总结
Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients Materials and Methods: The current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after the intervention.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg
- •lack of pregnancy
- •no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen,
- •no history of liver diseases,
- •no acute or chronic structural or functional nasal obstruction diseases,
- •no history of drug or psychiatric addiction,
- •no pain medication within the past four hours,
- •no history of heart disease,
- •and the presentation of the written consent to participate in the study.
排除标准
- •a decrease in GCS score to less than or equal to 14,
- •an elevated systolic blood pressure to higher than 180 mmHg,
- •a decreased diastolic blood pressure to less than 80 mmHg,
- •inability to understand the VAS pain rating system,
- •symptoms of acute heart disease and respiratory depression (respiratory rate <8 / min),
- •and the patient's dissatisfaction to continue the cooperation in study
研究组 & 干预措施
Control (Placebo+ Standard of Care))
干预措施: Placebo (Drug)
Ketamine + Standard of Care
干预措施: Ketamine (Drug)
Fentanyl + Standard of Care
干预措施: Fentanyl (Drug)
结局指标
主要结局
Visual analogue score
时间窗: Change from baseline at 40 minutes
a scale for measuring the extent of pain relief
次要结局
- Heart rate (HR)(Change from baseline at 40 minutes)
- Blood pressure (BP)(Change from baseline at 40 minutes)
- Respiratory rate (RR)(Change from baseline at 40 minutes)
- SPO2(Change from baseline at 40 minutes)
研究者
Mehdi Nasr Isfahani
Dr.
Isfahan University of Medical Sciences