NCT03335007已完成2 期
Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment: A Randomized, Double-blind, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Postendodontic pain rate change
研究概览
简要总结
The aim of this prospective, randomized, double-blind, clinical trial is to evaluate the effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at 6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic intake after single-visit root canal treatment.
详细描述
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before the initiation of single-visit endodontic therapy. Each participant will receive a standard inferior alveolar nerve block injection of 1.8 ml of 2% mepivacaine with 1:100,000 epinephrine. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
- Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 24, and 48 hours postoperatively using Heft-Parker visual analogue scale (HP-VAS). Postoperative pain at injection area will be assessed at 6,24 and 48 hours using HP-VAS. Analgesic intake throughout the 48 hours will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in good health (American Society of Anesthesiologists Class I or Class II).
- •Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- •Age is 18 years or older.
- •Patients who can understand Heft- Parker Visual Analogue Scales.
- •Patients able to sign informed consent.
排除标准
- •Patients allergic to aceclofenac or Mepivacaine.
- •Pregnant or nursing women.
- •Patients having active pain in more than one molar in the same quadrant.
- •Administration of analgesics within 12 h before the administration of the study drug.
研究组 & 干预措施
Aceclofenac
Experimental
Aceclofenac 100 mg tablet
干预措施: Aceclofenac (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Postendodontic pain rate change
时间窗: At 6, 24 and 48 hours after root canal treatment.
Postendodontic pain will be measured using Heft-Parker visual analogue scale. No or mild pain response will be considered success.
次要结局
- Analgesic intake(Within 48 hours after single root canal treatment.)
- Postoperative pain at injection area(At 6, 24 and 48 hours after root canal treatment.)
研究者
Nermeen AwadAllah Abbas Ibrahim
Principal Investigator, Cairo University
Cairo University
研究点 (1)
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