Evaluation of effect of addition of magnesium sulphate to lignocaine hydrochloride on pulpal anesthesia achieved after administration of inferior alveolar nerve block in children: a prospective, split mouth, randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Primary outcome is to evaluate and compare the effect of pulpal anesthesia achieved when inferior alveolar nerve block is given with lignocaine hydrochloride containing magnesium sulphate to that of inferior alveolar nerve block containing lignocaine hydrochloride without magnesium sulphate in treatment of irreversible pulpitis in primary mandibular second molars. Pulpal Pain levels of the patient while performing pulpectomy procedure will be assessed after intervention.
研究概览
简要总结
This study is a prospective, split mouth, double blinded, randomized control trial to evaluate the effect of addition of 0.18ml of 2mg/kg magnesium sulphate to 2% lignocaine hydrochloride on pulpal anesthesia achieved after administration of inferior alveolar nerve block in children having irreversible pulpitis in primary mandibular second molars. Study will be done in a single center in Manipal, India with a sample size of 35 children. The primary outcome measures will be to evaluate and compare the effect of pulpal anesthesia achieved when magnesium sulphate is added to lignocaine hydrochloride local anesthesia to that of a regular lignocaine local anesthesia. Secondary outcome measures will be to measure the onset, duration of anesthesia and adverse effects on adding magnesium sulphate to lignocaine hydrochloride local anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in 6 years to 9 years of age group with ability to understand pain record scales With positive or definitely positive behavior as per Frankel behavior rating scale With parental consent With primary mandibular second molars showing symptoms of irreversible pulpitis having lingering response to cold test With moderate to severe pain in Heft Parker Visual Analogue scale after cold test With no radiographic alterations of periodontal ligament space and fully formed roots.
排除标准
- •Patients having history of allergies to magnesium sulphate or local anesthesia or other medications Uncooperative patients Patients having history of significant medical conditions Patients taking beta blockers and opioids preoperatively Patients with primary mandibular second molars with signs of irreversible pulpitis with no pain responding normally to cold test Presence of periodontal ligament space enlargement and presence of periapical radiolucency in radiographic examination.
结局指标
主要结局
Primary outcome is to evaluate and compare the effect of pulpal anesthesia achieved when inferior alveolar nerve block is given with lignocaine hydrochloride containing magnesium sulphate to that of inferior alveolar nerve block containing lignocaine hydrochloride without magnesium sulphate in treatment of irreversible pulpitis in primary mandibular second molars. Pulpal Pain levels of the patient while performing pulpectomy procedure will be assessed after intervention.
时间窗: Pain levels will be assessed for a span of 1 hour while doing pulpectomy after administering nerve block.
次要结局
- Secondary outcome is the onset duration and adverse affects on adding magnesium sulphate to lignocaine hydrochloride local anesthesia in inferior alveolar nerve block(24 hours)