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Antihistamine

Midazolam for Pediatric Dental Sedation

Phase 4
Waitlist Available
Led By Travis M Nelson, DDS
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at completion of procedure
Awards & highlights

Study Summary

This trial is testing whether a commonly used oral sedation regimen for dental work in children is just as effective without a narcotic component.

Eligible Conditions
  • Pediatric Dental Sedation
  • Meperidine
  • Tooth Decay
  • Hydroxyzine
  • Midazolam

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Successful Sedation
Secondary outcome measures
Child Temperament According to CBQ-SF and Association With Sedation Outcomes

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Midazolam, HydroxyzineExperimental Treatment2 Interventions
Participants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure.
Group II: Midazolam, Hydroxyzine, MeperidineActive Control3 Interventions
Participants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, Hydroxyzine 1.0mg/kg, and Meperidine 1.5mg/kg prior to their dental procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
FDA approved
Hydroxyzine
FDA approved

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,749 Previous Clinical Trials
1,838,607 Total Patients Enrolled
Travis M Nelson, DDSPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
13 Total Patients Enrolled
~6 spots leftby May 2025