EFFICACY OF ORAL MELATONIN AND ORAL TRICLOFOS AS SEDATIVE FOR CHILDREN UNDERGOING DENTAL TREATMENT: A CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Melatonin was better than Triclofos Sodium, but both can be used as premedication drugs.
研究概览
简要总结
Aim: To compare the pre and post use of oral Melatonin and oral Triclofos as oral sedative drug on anxiety, sedation, cognitive and psychomotor function to perform satisfactory dental treatment on uncooperative children.
Materials and Methodology: A total number of 100 patients age range between 4 to 9 years were scheduled for dental treatment were randomly divided into two groups as Group I and II and administered with Melatonin and Triclofos Sodium respectively to determine changes in anxiety, cognitive, psychomotor and sedation score pre and post treatment. Data were analysed using an unpaired/paired *t-*test and P < 0.05 was contemplate statistically significant.
Result: Inpre and post treatment results,there were decreased incognitive scores and anxiety scores significantly, and sedation scores were increased after 60 mins of Melatonin and Triclofos medication. When both medicines compared, Melatonin showed better sedative effect and more reduction in anxiety score than Triclofos Sodium with insignificant differences.
Conclusion: Both melatonin and triclofos sodium are effective drugs that can be used as potent premedication to reduce anxiety associated with dental procedures.
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
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •children of age group 4-9 years with Frankl’s behavior rating scale 2, 3 and the American Society of Anaesthesiologists (ASA) I and II physical status.
排除标准
- •Frankel behavior rating scale 1, 4, patients with developmental delays, preterm, and a history of chronic disease.
结局指标
主要结局
Melatonin was better than Triclofos Sodium, but both can be used as premedication drugs.
时间窗: Immediately after 60 minutes of administration.
次要结局
- Melatonin causes more sedation than Triclofos Sodium.(after 2 hours of administration no side effects were seen in Melatonin group but some side effects were seen in triclofos group)
研究者
Rohan Shrivastava
K.D. Dental College and Hospital