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临床试验/CTRI/2023/12/060666
CTRI/2023/12/060666已完成4 期

Physiological and psychological effectiveness of rapid and slow induction of nitrous oxide inhalation sedation in a pediatric patient undergoing dental procedure: A randomized clinical study

Dr Sneha Dori1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
78
试验地点
1
主要终点
pain scale, sedation scale

研究概览

简要总结

Nitrous oxide–oxygen (N2O–O2) inhalation sedation has been recognized as a safe and effective technique to reduce anxiety, produce analgesia, and enhance effective communication between a patient and a health�’care provider. N2O is a nonirritating, colorless, inert gas with a faint sweet smell and odor. During rapid induction, pre adjusted concentrations of N2O with O2 is administered directly as a STAT dose in an uncooperative child till he/she gains his/her composure. After the child settles down, N2O concentrations are appropriately adjusted either upward or downward. very few studies have mentioned the efficacy of the rapid induction technique using preadjusted mix of 30% N2O + 70% O2 for sedation in children while comparing it with 50% N2O+ 50% O2 and monitoring the procedure for adverse effects such as hypoxia, nausea, and vomiting. according to null hypothesis There is no difference in changes in physiological and psychomotor effects on pediatric patients under different concentrations of N2O –O2 inhalation sedation.The current study aims to evaluate and compare the changes in physiological and psychomotor effects on pediatric patients under different concentrations of N2O –O2 inhalation sedation and to analyze the post-sedation effects of nitrous oxide sedation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) Physical Status I and II Frankl behaviour rating scale of 3 and 4 Preoperative heart rate of 80 to 140 beats per minute and Respiratory rate of 24-30 beats per minute.
  • A maximum blood pressure reading of 140/100 mmHg. Patients who require LA administration for dental procedures.

排除标准

  • Patient with any chronic systemic illness.
  • Parents who did not give consent Children with active upper respiratory tract infections, obstructive mouth breathing Predisposing factors causing airway obstruction such as adenoid hyperplasia, nasal septum problems, nasal polyps, and enlarged turbinates.
  • Patients having claustrophobia.

结局指标

主要结局

pain scale, sedation scale

时间窗: 24 hours, 24 hours

次要结局

  • psychomotor scale(24 hour)

研究者

发起方
Dr Sneha Dori
申办方类型
Research institution and hospital

研究点 (1)

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