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Safety and Efficacy of Intranasal Dexmedetomidine

NCT02985697 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-12-07

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine when used in combination with oral midazolam and/or nitrous oxide for moderate sedation during pediatric outpatient dental procedures.

Conditions

  • Safety and Efficacy of Intranasal Dexmedetomidine

Interventions

DRUG

Dexmedetomidine

The intervention being tested is intranasal dexmedetomidine

DRUG

Midazolam Hydrochloride

Oral midazolam is being used as the Active Comparator. It will also be used in conjunction with IN dexmedetomidine in some experimental groups.

DRUG

Nitrous Oxide

Nitrous oxide to be administered in conjunction with other interventions, per study design.

Sponsors & Collaborators

  • Bon Secours Pediatric Dental Associates

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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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 NCT02985697 on ClinicalTrials.gov