Effect of Preoperative Acetaminophen-Codeine-Caffeine Combination on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis: Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.
研究概览
简要总结
The aim of the study is to evaluate the effect of preoperative administration of acetaminophen- codeine -caffeine combination on the success of the inferior alveolar nerve block versus bacetaminophen alone or placebo in patients with symptomatic irreversible pulpitis.
详细描述
After ensuring eligibility, patients will be given premedication 1hr before treatment,which will be done in single visit.
After 1 hour, Pretreatment pain "pain after administration of analgesic or placebo" will be recorded using 0-10 numerical rating scale (NRS) .
Local anesthesia will, then, be done through inferior alveolar nerve block using 1.8 ml Mepivacaine.
The teeth will be isolated using rubber dam and access cavity will be prepared using #2 high-speed round bur.
The patients will be asked to rate their pain on the NRS. The degree of pain during access preparation and/or instrumentation will be recorded.
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
- Double (Participant, Care Provider)
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 aging between 18-50 years old.
- •Patients with mandibular molar with symptomatic irreversible pulpitis.
- •Systemically- healthy patients.
- •Patients who agree to attend for recall appointments and provide a written consent.
排除标准
- •Pregnant or lactating female patients.
- •Patients had allergies to any of test medications.
- •Patients had taken analgesics medication within the last 6 hours.
- •Moderate or severe marginal periodontitis i.e. pocket probe>3mm.
- •Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease
研究组 & 干预措施
Acetaminophen, codeine,and caffeine
Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine.
干预措施: Acetaminophen and codeine and caffeine (Drug)
Acetaminophen
Oral single dose of 1000mg acetaminophen.
干预措施: Acetaminophen (Drug)
Placebo
Maize starch.
干预措施: Placebo (Drug)
结局指标
主要结局
Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.
时间窗: During the treatment
Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
次要结局
未报告次要终点
研究者
Alaa Mohammed Abdallah Morsi
Post graduate student, Department of Endodontics, Faculty of Dentistry,Cairo University
Cairo University