Effect of Diclofenac Potassium Premedication Dose on Anesthetic Success and Post-operative Pain in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Anesthetic success of articaine buccal infiltration
研究概览
简要总结
The aim of this study is to assess the effect of different doses of diclofenac potassium premedication (100mg vs 50mg) on anesthetic success of 4% articaine buccal infiltration and post-operative pain as compared to placebo in mandibular molars with symptomatic irreversible pulpitis.
详细描述
Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (100mg), diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of articaine buccal infiltration will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.
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 with symptomatic irreversible pulpitis.
- •Patients with moderate to severe pain.
- •Mandibular molars
- •Patients with the ability to understand and use the pain scale
排除标准
- •Patients allergic to any medication or material to be used in the study.
- •Pregnant and lactating females.
- •Patients taking medications affecting pain perception in the last 12 hours.
- •Patients having more than one symptomatic molar in the same quadrant.
- •Patients with contributory medical history (ASA I or II).
结局指标
主要结局
Anesthetic success of articaine buccal infiltration
时间窗: During the treatment
Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.
次要结局
- Postoperative pain at 6 hours(6 hours)
- Postoperative pain at 12 hours(12 hours)
- Postoperative pain at 24 hours(24 hours)
- Postoperative pain at 48 hours(48 hours)
- Postoperative pain at 72 hours(72 hours)
- Postoperative pain at 7 days(7 days)
研究者
Ameena Khaled Omar Bagunaid
Postgraduate student
Cairo University