NCT00406679已完成3 期
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Dental Pain Model
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
研究概览
简要总结
The aim of the study is to evaluate the therapeutic efficacy and safety of two different paracetamol-containing solutions in postoperative dental pain. They will be compared to placebo (a dummy treatment which contains no active ingredient).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal.
- •Moderate or severe pain within 4 hours after the completion of surgery.
排除标准
- •Another acute or chronic painful physical condition
- •Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
- •Inability to use and understand Visual Analog Scale and Verbal Rating Score
研究组 & 干预措施
3
Active Comparator
干预措施: paracetamol (acetaminophen) solution commercial (Drug)
1
Experimental
干预措施: Paracetamol (acetaminophen) solution experimental (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
研究者
研究点 (2)
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