High-Concentration Nitrous Oxide for Dental Procedural Sedation in Children

Overview

The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In concentrations up to 50% it is considered as mild sedation and it is very safe. Despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Higher concentration was not conducted in Pediatry densitery. The aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2018

Detailed Description

Nitrous oxide/oxygen in varying concentrations has been successfully used for many years to provide sedation and analgesia for a variety of painful procedures in children. The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In concentrations up to 50% it is considered as mild sedation and it is very safe. It is usually used for mild or moderate anxiety state because it is not so potent in concentrations up to 50 %. Despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Nitrous oxide 50% is the most common concentration in use but the results of the sedation does not always provide a satisfactory cooperation, higher concentration was not conducted in Pediatry densitery. The aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.

Interventions

  • Drug: Nitrous Oxide
    • Nitrous Oxide at 60%-70% concentration administrated by mask, to achieve cooperation in Pediatric dentisry

Arms, Groups and Cohorts

  • Experimental: nitrous oxide
    • Administration of high concentration of nitrous oxygen in pediatric dentistry

Clinical Trial Outcome Measures

Primary Measures

  • Achieving cooperation in Pediatric dentistry numerical scale
    • Time Frame: less than 60 minutes

Participating in This Clinical Trial

Inclusion Criteria

  • Children evaluated by a senior pediatric dentist and require a wide treatment of caries, with a high score of anxiety unable to accept dental treatment with nitrous oxide /oxide of 50% in combined with behavioral management in the pediatric dental clinic. Exclusion criteria:

  • Children with high potential risk of sedation, snoring, stridor, sleep apnea, maxillofacial malformation, history of airway difficulty, gastro esophageal reflux, reactive airway disease or acute runny nose, cardiac disease, altered mental status, inadequate fasting time. – Parental refusal for conscious sedation.

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bnai Zion Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: MOSTAFA.SOMRI, M.D. – Bnai Zion Medical Center
  • Overall Official(s)
    • Mostafa Somri, M.D., Principal Investigator, Bnai Zion Medical Center
  • Overall Contact(s)
    • Mostafa Somri, M.D., # 972-4-8359304, mostafa.somri@b-zion.org.il

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