NCT00488787已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Efficacy of 10 mg, 30 mg, and 50 mg of Transnasal Ketamine Hydrochloride (PMI-100) for the Treatment of Postoperative Dental Pain
Javelin Pharmaceuticals0 个研究点目标入组 40 人开始时间: 2001年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- total pain relief over 0-3 hours following dosing
研究概览
简要总结
Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3 hours post administration and assess pain intensity and pain relief throughout the 3 hour postoperative period.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients at least 16 years of age requiring two or more third molar extractions
排除标准
- •Less than 16 years old
- •Other exclusion criteria may apply
研究组 & 干预措施
A
Experimental
Intranasal ketamine low dose
干预措施: intranasal ketamine (Drug)
B
Experimental
intranasal ketamine medium dose
干预措施: intranasal ketamine (Drug)
C
Experimental
intranasal ketamine high dose
干预措施: intranasal ketamine (Drug)
D
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
total pain relief over 0-3 hours following dosing
时间窗: 3 hours
次要结局
- other pain assessments(3 hours)
研究者
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