Effect of Pre-operative Diclofenac Potassium on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Cases With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- anesthetic success
研究概览
简要总结
The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.
详细描述
Objective
The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.
Design: Randomized double-blind controlled trial.
Setting and conduct:
- Patients source: Out patients of the clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
- 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 50 mg diclofenac potassium packet) and the control group (taking a placebo packet). Each packet will be taken 30 minutes before starting treatment. The patient's pain will be assessed before local anesthetic administration using Heft- Parker Visual Analog Scale (HP- VAS). . After 15 minutes of the initial inferior alveolar nerve block (IANB) of 1.8 ml of 2% mepivacaine hydrochloride with 1:100000 epinephrine, the teeth will be examined using a cold pulp sensitivity test; in case of lip numbness together with no or mild pain on cold, the treatment will be initiated.
- During root canal treatment, no to mild pain response on HP- VAS will be considered success. In case of failure, supplemental anesthesia will be administered.
- Main outcome measures: Anesthetic success during root canal treatment using HP VAS.
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 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in good health as determined by a medical history and oral questioning. (ASA I or II)
- •Age range is between 18 and 50 years.
- •Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
- •Patients who can understand Heft Parker Visual Analogue Scales VAS.
- •Patients accepting to participate in the study and able to sign informed consent.
排除标准
- •Pregnant female patient.
- •Patients allergic to diclofenac potassium or mepivacaine.
- •Patients having active pain in more than one mandibular molar.
- •Patients who had taken analgesics in the 12 hours preceding the injection.
研究组 & 干预措施
Placebo
placebo
干预措施: Placebo (Other)
Diclofenac potassium
Diclofenac potassium 50 mg
干预措施: Diclofenac potassium (Drug)
结局指标
主要结局
anesthetic success
时间窗: Intraoperative
Pain during treatment is measured using Heft Parker VAS
次要结局
- Pain on injection of initial IANB(Intraoperative)
研究者
Aya Ahmed Youssef
Postgraduate student
Cairo University
