Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change from Baseline in depth of anesthesia
研究概览
简要总结
Achievement of a deep and long-durated anesthesia is vital before most endodontic procedures; therefore, the investigators conducted this study to compare the local infiltration effect of epinephrine-containing lidocaine with/ without fentanyl on depth and duration of anesthesia in maxillary molars with painful irreversible pulpitis.
详细描述
This study was planned with a randomized double-blind, parallel design clinical trial on 64 healthy patients after taking into account some inclusion and exclusion criteria. The control group were received the mixture of normal saline and 2% lidocaine with 1:200,000 epinephrine and the experimental group were received the mixture of fentanyl and 2% lidocaine with 1:200,000 epinephrine. The depth and duration of pulpal anesthesia were evaluated with an electric pulp testing in 5-minute intervals during a period of 60 minutes and the pain intensity recorded in five times, before injection, after injection, during access cavity preparation, pulpotomy and pulpectomy using visual analog scale(VAS). All data were analyzed and compared using chi-squared and Mann-Whitney tests.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were aged between 18 and 65 years with no systemic diseases categorized in the Class I ASA;
- •Individuals requiring urgent root canal treatment of maxillary first or second molars;
- •Hot painful teeth with irreversible pulpitis (moderate to severe spontaneous pain), with a positive response to thermal vitality tests (a long painful response to a cold test) and no clinical or radiographic signs or symptoms of acute or chronic apical periodontitis; and
- •No history of taking analgesics in the previous 12 h.
排除标准
- •Systemic conditions;
- •Allergic reactions to opioids, benzodiazepines, barbiturates;
- •Pregnancy and lactation; Contraindication of the use of epinephrine (such as unstable angina);
- •Nonvital pulp after access cavity preparation
研究组 & 干预措施
Lidocaine with Epinephrine+ Normal saline
干预措施: Lidocaine with Epinephrine+ Normal saline (Drug)
Lidocaine with Epinephrine+ Normal saline
干预措施: Lidocaine with Epinephrine + fentanyl (Drug)
Lidocaine with Epinephrine + fentanyl
干预措施: Lidocaine with Epinephrine+ Normal saline (Drug)
Lidocaine with Epinephrine + fentanyl
干预措施: Lidocaine with Epinephrine + fentanyl (Drug)
结局指标
主要结局
Change from Baseline in depth of anesthesia
时间窗: Change from Baseline up to 17 minutes
The measuring method of the pain is Electric pulp tester
次要结局
- change from baseline in intensity of the pain(Change from Baseline up to 60 minutes)
研究者
fatemeh khodaei
Resident of Endodontics
Islamic Azad University, Tehran