NCT02940405Unknown不适用
Effect of Ketorolac Premedication on Anesthetic Efficiency of Inferior Alveolar Nerve Block, Pre-Treatment and Post-Endodontic Pain in Teeth With Irreversible Pulpitis: A Randomized Controlled Double Blinded Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 主要终点
- Anesthetic efficiency
研究概览
简要总结
The aim of this study to assess effect of ketorolac premedication on the effectiveness of the inferior alveolar nerve block, pretreatment and postoperative pain in patients with symptomatic irreversible pulpitis.
详细描述
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 10 mg tablet of ketorolac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. The patient's pain will be assessed before local anesthetic adminstration. 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.
- During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.
- Postoperative pain will be assessed 6, 12, 24 and 48 hours after treatment. The number of patients who will require rescue analgesic medication within the 48 hours postoperatively will be counted.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-45 years old.
- •Males or Females.
- •Mandibular Posterior teeth with symptomatic irreversible pulpitis.
- •Patients with non-contributory systemic condition.
排除标准
- •Patients allergic to any analgesics or antibiotics or anesthetics
- •Pregnant females
- •If analgesics have been administrated during the past 8 hours before endodontic treatment.
- •Irrestorable teeth.
研究组 & 干预措施
ketorolac tromethamine
Experimental
One tablet of Ketorolac tromethamine 10-mg one hour before endodontic treatment
干预措施: Ketorolac Tromethamine (Drug)
placebo tablet
Placebo Comparator
One tablet of a placebo one hour before endodontic treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Anesthetic efficiency
时间窗: Intraoperative (During endodontic treatment)
Pain during endodontic treatment will be assessed using a numerical rating scale (NRS). No or mild pain response will be considered success.
次要结局
- Postoperative pain(At 6,12, 24, 48 hours after root canal treatment)
- Number of patients requiring rescue analgesic.(Within 48 hours after endodontic treatment)
研究者
Laila Zakaria Ismail
Resident at endodontic departement , Faculty of Oral and Dental medicine ,Cairo University
Cairo University
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