High-Concentration Nitrous Oxide for Dental Procedural Sedation in Children

NCT02886351 | Unknown DMC

• 1 other identifier: BnaiZionMC-16-MS-002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Anxiety

Keywords

Moderate Sedation; Pediatric Dentistry; Anxiety

Outcome Measures

Primary Outcomes (1)

• Achieving cooperation in Pediatric dentistry numerical scale

  less than 60 minutes

Study Arms (1)

nitrous oxide

EXPERIMENTAL

Administration of high concentration of nitrous oxygen in pediatric dentistry

Drug: Nitrous Oxide

Interventions

Nitrous Oxide DRUG

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

Also known as: Dinitrogen monoxide, laugh gas

nitrous oxide

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Nitrous Oxide; Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mostafa Somri, M.D.

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Somri, M.D.

CONTACT

# 972-4-8359304; mostafa.somri@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 28, 2016
• First Posted: September 1, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share