跳至主要内容
临床试验/NCT03163420
NCT03163420Unknown2 期

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

Cairo University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

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

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 Comparator

placebo

干预措施: Placebo (Other)

Diclofenac potassium

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Ahmed Youssef

Postgraduate student

Cairo University

研究点 (1)

Loading locations...

相似试验