National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Tiradentes association in adolescents and adults with acute pain.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Participants of both sexes, aged 15 years or more;
- •Participants who require extraction of impacted mandibular third molar;
- •Third molar with bone impactions observed in panoramic radiography, with classification of Winter (1926) mesioangular or vertical, and classification according to Pell & Gregory (1933) class II position B or class III position A or B;
- •Participants with acute pain of moderate or severe intensity after completion of surgery.
排除标准
- •Known hypersensitivity to the formula components used during the clinical trial;
- •History of alcohol and/or substance abuse within 2 years;
- •Participants whose surgery for molar extraction lasted more than 50 minutes;
- •Participants with known gastroduodenal ulcers or diagnosis of persistent gastritis;
- •Participants who used sedatives or hypnotic agents before surgery;
- •Anesthesia technical failure or need for more than three anesthetic tubes;
- •Participants with temporomandibular joint dysfunction or limited mouth opening;
- •Surgical accident that, in the investigator's opinion, may interfere with the procedures or evaluations of the trial;
- •Postoperative complications such as, but not restricted to: neuropraxia and paresthesia;
- •Participants who used any medication that acts on the pain mechanism in the 3 days prior to the start of the trial;
- •Participants under chronic opioid treatment.
研究组 & 干预措施
TIRADENTES
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 tablet Tiradentes association, oral;
1 capsule tramadol placebo, oral;
1 tablet dipyrone placebo, oral.
干预措施: TIRADENTES ASSOCIATION (Drug)
TIRADENTES
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 tablet Tiradentes association, oral;
1 capsule tramadol placebo, oral;
1 tablet dipyrone placebo, oral.
干预措施: DIPYRONE PLACEBO (Other)
TIRADENTES
The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 tablet Tiradentes association, oral;
1 capsule tramadol placebo, oral;
1 tablet dipyrone placebo, oral.
干预措施: TRAMADOL PLACEBO (Other)
DIPYRONE
The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 tablet dipyrone, oral;
1 tablet Tiradentes association placebo, oral;
1 capsule tramadol placebo, oral.
干预措施: DIPYRONE (Drug)
DIPYRONE
The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 tablet dipyrone, oral;
1 tablet Tiradentes association placebo, oral;
1 capsule tramadol placebo, oral.
干预措施: TIRADENTES ASSOCIATION PLACEBO (Other)
DIPYRONE
The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 tablet dipyrone, oral;
1 tablet Tiradentes association placebo, oral;
1 capsule tramadol placebo, oral.
干预措施: TRAMADOL PLACEBO (Other)
TRAMADOL
The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 capsule tramadol, oral;
1 tablet dipyrone placebo, oral;
1 tablet Tiradentes association placebo, oral.
干预措施: TRAMADOL (Drug)
TRAMADOL
The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 capsule tramadol, oral;
1 tablet dipyrone placebo, oral;
1 tablet Tiradentes association placebo, oral.
干预措施: TIRADENTES ASSOCIATION PLACEBO (Other)
TRAMADOL
The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 capsule tramadol, oral;
1 tablet dipyrone placebo, oral;
1 tablet Tiradentes association placebo, oral.
干预措施: DIPYRONE PLACEBO (Other)
结局指标
主要结局
Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6)
时间窗: 0-6 hours
Sum of pain intensity differences after 6 hours (SPID0-6), calculated as the weighted sum of pain intensity scale over 6 hours after the dose. Scoring is derived from the 4-point scale, which 0= no pain, 1= mild pain, 2= moderate pain and 4= severe pain.
次要结局
- Incidence and severity of adverse events recorded during the study.(26 days)