A comparative evaluation to check the efficacy of 5% Eutectic mixture of local anesthetic cream with customized oral mucosal vibrator (Oravibe) during administration of greater palatine nerve block in patients undergoing therapeutic extractions. A Split Mouth Randomized Controlled Trial.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Injection pain intensity during the greater palatine nerve block, measured on a 0–10 VAS (NRS) (0=worst imaginable pain, 10=no) immediately after injection on each side in the split-mouth design. The score recorded is the highest pain felt during needle penetration and anesthetic deposition.
研究概览
简要总结
Primary outcome Injection pain intensity on NRS 0 to 10 measured at peak during injection immediately after 5 minutes and 10 minutes
Secondary outcomes Pain of topical application and vibration tolerance Latency and success of anesthesia Soft tissue changes and wound healing Patient anxiety satisfaction and functional recovery Intraoperative pain and need for rescue anesthesia Operator ease of procedure Physiological responses heart rate and blood pressure Adverse events and analgesic consumption
Secondary outcome time points concise Immediate 0 to 2 minutes 5 to 10 minutes intraoperative 30 minutes 2 hours 24 hours Day 1 Day 7 Day 14 as relevant to each outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients advised Bilateral maxillary ortho extraction Requiring palatal injection Patient having healthy palatal mucosa Healthy patients without any allergy or systemic disease Patient who will give consent for study.
排除标准
- •Patient with a history of allergic reactions to local anaesthetics Patients with any bleeding disorder Patient giving history of taking any medications that interacts with local anesthetics Patient who does not give consent for study.
结局指标
主要结局
Injection pain intensity during the greater palatine nerve block, measured on a 0–10 VAS (NRS) (0=worst imaginable pain, 10=no) immediately after injection on each side in the split-mouth design. The score recorded is the highest pain felt during needle penetration and anesthetic deposition.
时间窗: Injection pain intensity during the greater palatine nerve block, measured on a 0–10 VAS (NRS) (0=worst imaginable pain, 10=no) immediately after injection on each side in the split-mouth design. The score recorded is the highest pain felt during needle penetration and anesthetic deposition.
次要结局
- Pain of topical application
研究者
Dr Pracheta Watane
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital