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Nitrous Oxide Prior to Intranasal Midazolam for Moderate Dental Sedation in Pediatric Patients

2019-09-13 02:15:38 | BioPortfolio

Summary

The purpose of this study is to assess the effectiveness of nitrous oxide/oxygen administration in reducing the discomfort of intranasal midazolam administration for moderate sedation for dental procedures.

Description

This study will determine the effectiveness of two different concentrations of nitrous oxide for reducing the pain of intranasal midazolam when given for subjects already planned for moderate sedation for completion of dental procedures in the pediatric dental clinic. Moderate dental sedation is useful because it helps relieve anxiety and make the dental procedure less memorable and more comfortable for the patient. Sedation appointments typically go smoothly when the patient is calm rather than when the patient is upset. Giving midazolam through the nose can be painful and the dental provider risks upsetting a patient and causing the sedation appointment to fail. Therefore, the goal of this study is to test whether nitrous oxide administration is effective in reducing the pain from intranasal midazolam administration. The effectiveness will be measured by the primary outcome of heart rate pre- and post- midazolam administration for the two randomly assigned study arms. The first study arm will be given 30% nitrous/70% oxygen and the second study arm will be given 70% nitrous/30% oxygen prior to the midazolam administration. The secondary outcome will compare subject, dental provider, and the parent/guardian answers to questions regarding the subject's experience pre- and post- midazolam administration. The investigators hypothesize lower changes in heart rate and less pain reported following midazolam administration in subjects given 70% nitrous oxide.

Study Design

Conditions

Dental Anxiety

Intervention

Nitrous Oxide, Midazolam

Location

Children's Hospital Colorado
Aurora
Colorado
United States
80045

Status

Recruiting

Source

Children's Hospital Colorado

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-13T02:15:38-0400

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Medical and Biotech [MESH] Definitions

Nitrogen oxide (N2O). A colorless, odorless gas that is used as an anesthetic and analgesic. High concentrations cause a narcotic effect and may replace oxygen, causing death by asphyxia. It is also used as a food aerosol in the preparation of whipping cream.

Abnormal fear or dread of visiting the dentist for preventive care or therapy and unwarranted anxiety over dental procedures.

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Used as a dental cement this is mainly zinc oxide (with strengtheners and accelerators) and eugenol. (Boucher's Clinical Dental Terminology, 4th ed, p50)

A technique using a pneumatic, high-pressure stream of aluminum oxide to remove DENTAL ENAMEL; DENTIN; and restorative materials from teeth. In contrast to using DENTAL HIGH-SPEED EQUIPMENT, this method usually requires no dental anesthesia (ANESTHESIA, DENTAL) and reduces risks of tooth chipping and microfracturing. It is used primarily for routine DENTAL CAVITY PREPARATION.

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