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临床试验/CTRI/2024/05/066652
CTRI/2024/05/066652尚未招募Phase 3 4

Comparative Evaluation of Two Different Induction Techniques of Nitrous Oxide Sedation – A Randomized Clinical Trial

Not Applicable1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
To compare and evaluate the differences in salivary cortisol levels, physiological psychomotor parameters and analgesic effects between the rapid and slow titration induction techniques

研究概览

简要总结

Nitrous oxide (N2O) is a recognized method in pediatric dentistry for reducing anxiety and enhancing communication. It can be administered rapidly in uncooperative children or slowly with gradual concentration increases. Anxiety triggers the release of cortisol through the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system. The American Academy of Pediatric Dentistry (AAPD) acknowledges N2O’s efficacy in reducing anxiety levels and facilitating effective patient-doctor communication. This method offers a safe and effective approach to managing anxiety in pediatric patients, allowing for improved cooperation during dental procedures.The aim of this study is to compare and evaluate the variations in physiological, psychomotor parameters and analgesic effects in 4–8-year-old children undergoing pulpal therapy under nitrous oxide sedation using two different induction techniques. The patient will be made to sit on the dental chair and will be examined under a strict sterilization protocol. The patient’s behavior will be assessed according to the Frankl’s behavior rating scale following which the pre-op saliva would be collected – approx. 1ml and physiological, psychomotor parameters and analgesic effects will be recorded . Then the nitrous oxide sedation would be initiated as per the nitrous oxide induction protocol and the induction technique will be based on the randomized block design. Administration of the local anesthetic agent and the pulp therapy procedure will be carried out. After induction, the salivary sample will be recollected and all the other parameters will be re recorded.The samples will be sent for salivary biomarker level analysis to the microbiology lab .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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 aged 4-8 years Frankl’s Behavior Rating 2 (negative), 3 (positive) ASA I category children Primary teeth indicated for vital pulp therapy Children with no previous experience of intraoral local anesthesia Children whose parent / guardian gives written consent for the procedure.

排除标准

  • Children with upper respiratory tract infection Children with blocked nose Patient with extraoral and intraoral swellings Patient with any systemic disease Children with special healthcare needs Children allergic to local anaesthetic agent (after test dose).

结局指标

主要结局

To compare and evaluate the differences in salivary cortisol levels, physiological psychomotor parameters and analgesic effects between the rapid and slow titration induction techniques

时间窗: base line and post sedation

次要结局

  • To evaluate the pre & post-op physiological parameters when using the rapid titration induction technique(To evaluate the pre & post-op salivary cortisol levels when using the rapid titration induction technique)

研究者

发起方
Not Applicable
申办方类型
Other [Not Applicable]
责任方
Principal Investigator
主要研究者

HADEEL FAROOQ

Manav Rachna Dental College

研究点 (1)

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