Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 主要终点
- Anesthetic success of inferior alveolar nerve block
研究概览
简要总结
The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients 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 (50mg)- acetaminophen (1000mg) combination, 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 inferior alveolar nerve block 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic irreversible pulpitis with/without mechanical allodynia
- •Patients with moderato to severe spontaneous pain
- •Mandibular molars
- •Patients with the ability to understand and use the pain scale
- •Patients accepting enrollment in the study
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 > II)
研究组 & 干预措施
Diclofenac potassium- acetaminophen combination
Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination
干预措施: Diclofenac potassium- acetaminophen combination (Drug)
Diclofenac potassium
Preoperative single dose of diclofenac potassium(50mg)
干预措施: Diclofenac potassium (Drug)
Placebo
Preoperative single dose of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Anesthetic success of inferior alveolar nerve block
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
Sovana Tarek
Postgraduate student
Cairo University