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High-Concentration Nitrous Oxide for Dental Procedural Sedation in Children

NCT02886351 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-09-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nitrous Oxide

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

Sponsors & Collaborators

  • Bnai Zion Medical Center

    lead OTHER_GOV

Principal Investigators

  • Mostafa Somri, M.D. · Bnai Zion Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-31
Completion
2018-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02886351 on ClinicalTrials.gov