drugset / Trial / NCT02886351

High-Concentration Nitrous Oxide for Dental Procedural Sedation in Children

NCT02886351

Unknown 30 enrolled Bnai Zion Medical Center
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-01
Primary completion
2018-01
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitrous Oxide Other / unclassified 50 % Other
Subject Nitrous Oxide Other / unclassified 60 % Other
Subject Nitrous Oxide Other / unclassified 70 % Other

Indications