Effect of Pre-operative Aceclofenac on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
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
- Anesthetic success
研究概览
简要总结
The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.
详细描述
- The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.
- 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 starting treatment. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated otherwise, additional IANB will be administered.
- During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.
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
Aceclofenac 100 mg tablet
干预措施: Aceclofenac (Drug)
placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Anesthetic success
时间窗: intraoperative
Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation which will be measured with Heft-parker VAS in which no or mild pain will be considered as anesthetic success and moderate or severe pain will be considered as anesthetic failure.
次要结局
- Pain on injection of inial IANB(intraoperative)
研究者
Nermeen AwadAllah Abbas Ibrahim
Principal Investigator, Cairo University
Cairo University