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临床试验/CTRI/2024/04/065765
CTRI/2024/04/065765尚未招募3 期

Comparative evaluation of effectiveness of interrupted and continuous nitrous oxide oxygen sedation as administration technique in anxious children of 4 to 8 years of age- A randomized controlled trial.

Dr Avani Ramesh Doiphode1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
1.Sedation level

研究概览

简要总结

Nitrous oxide -oxygen conscious sedation (N2O- O2 sedation) is a commonly used technique in paediatric dentistry to manage anxiety and discomfort in patients undergoing dental procedures.This technique helps to reduce the physiological and psychological stress in anxious paediatric patients. Various benefits of using N2O- O2 sedation technique are its properties such as anxiolysis, mild analgesia, and amnesia.

 Nevertheless, nitrous oxide poses a potential risk to clinical staff regularly administering inhalational sedation. There is substantiated evidence that prolonged exposure to nitrous oxide gas may result in hematological, reproductive, and neurological issues. Although the use of scavenging equipment, proper techniques, and well-ventilated surgical environments has notably reduced staff exposure levels, there remains some residual pollution within the surgical setting.

 The traditional approach to N2O-O2 sedation involves the continuous administration of N2O- O2 throughout a dental procedure to ensure the ongoing cooperation of the patient. In the case of mildly to moderately anxious children, once profound local anesthesia has been established, it becomes possible to interrupt the continuous administration of N2O-O2 sedation while still effectively managing anxiety and maintaining desired behaviour. We assume that if behaviour issues related to local anesthetic administration alone have been successfully addressed, 100% oxygen may be administered, offering a potential means of reducing chronic exposure of the dental team to potentially hazardous levels of ambient nitrous oxide and to reduce the chance of over sedation to patient.

 Hence, this study is planned to investigate the impact and sedation level achieved by interrupted N2O-O2 sedation administration, following the achievement of profound local anesthesia, on the physical, physiological, psychological parameters and behaviour of paediatric dental patients with mild to moderate anxiety during the rehabilitation of molars.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children with ASA physical status classification I.
  • Patient with unilateral or bilateral carious first or second deciduous molar in need of treatment.
  • Children with anxiety score 3 or 4 on the Venhams anxiety scale.
  • Children with frankl behaviour rating of 3 or 4.

排除标准

  • Children below age of 4 years of age and above 9 years of age Children with ASA physical status classification II, III, IV.
  • Children with modified frankl’s behaviour rating scale 1 and
  • Highly uncooperative children.

结局指标

主要结局

1.Sedation level

时间窗: Baseline, during the treatment and post-treatment.

次要结局

  • 1.Psychomotor analysis(2. Behaviour of the patient)

研究者

发起方
Dr Avani Ramesh Doiphode
申办方类型
Other [Self Sponsored]
责任方
Principal Investigator
主要研究者

Dr Avani Ramesh Doiphode

Government Dental College and Hospital, Nagpur

研究点 (1)

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