Comparison of Ketorolac and Ketorolac/Acetaminophen on Success of Inferior Alveolar Nerve Block Injection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain rate using Visual Analog Scale (VAS) form
研究概览
简要总结
The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers including criteria, are participating. The patients will be divided into 3 groups and will be randomly given one of premedications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard Inferior Alveolar Nerve Block injection . Patients with no lip numbness and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.
详细描述
The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers with including criteria and with no spontaneous pain, reporting no or mild (Visual analog scale≤54) pain in response to cold testing and electric pulp tester, are participating. The patients will be divided into 3 groups on a random basis and will be randomly given one of the oral medications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard Inferior Alveolar Nerve Block injection with one carpule of 4% Articaine with 1:100000 Epinephrine. Patients with no anesthetic sign (lip numbness) and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with age ranged 18-65
- •without systemic diseases
- •without any medicine consumption
- •non smoking
- •non pregnant
- •non breast feeding
- •with asymptomatic irreversible pulpitis ( Visual Analog Scale ≤ 54) in one mandibular molar that needs root canal treatment
- •without any medicine consumption or analgesic and sedation
- •understand and sign the VAS and consent forms
排除标准
- 未提供
研究组 & 干预措施
Ketorolac tromethanine
This group will receive a caplet including10 mg Ketorolac tromethamine 45 minutes before applying infra alveolar nerve block injection.
干预措施: Ketorolac Tromethamine (Drug)
Acetaminophen
This group receive a caplet including10 mg Ketorolac tromethamine/ 1000 mg Acetaminophen, before applying the injection.
干预措施: Acetaminophen (Drug)
Placebo
This group receive a caplet including placebo, before applying the injection.
干预措施: Placebo (Other)
结局指标
主要结局
Pain rate using Visual Analog Scale (VAS) form
时间窗: 45 minutes
Pain during caries and dentin removal , access cavity preparation and working lengths measurements using VAS form.
次要结局
未报告次要终点
研究者
Nahid Mohammadzadeh Akhlaghi
Associate Professor
Azad University of Medical Sciences
