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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
1,739 Previous Clinical Trials
1,847,891 Total Patients Enrolled
Travis M Nelson, DDSPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
13 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does Midazolam stack up in terms of safety for individuals?

"There is enough evidence to confirm the safety of Midazolam, so it has earned a score of 3."

Answered by AI

Is it feasible for me to sign up as a participant in this clinical experiment?

"This trial is seeking 100 children between 3 and 7 years old who have dental caries. To qualify, they must be ASA I or II (clinically healthy, with a mild systemic illness) under 95th percentile in BMI for their age bracket, aged 36-95 months old and scheduled to visit the University of Washington Center for Pediatric Dentistry, as well as having Brodsky scores of II or less (tonsils that fill up no more than half the oropharyngeal opening)."

Answered by AI

For what medical issues is Midazolam frequently prescribed?

"Midazolam has proven to be efficacious for treating anxiety, anger issues, and anxiolysis."

Answered by AI

Is the age range of recruitment for this clinical trial inclusive of those over 20 years old?

"This research is seeking participants who are between 3 and 7 years old."

Answered by AI

What is the total enrollment for this clinical trial?

"The answer is affirmative. Clinicaltrials.gov attests to the active recruiting of this medical study, which was first advertised on June 25th 2019 and most recently updated on October 31st 2022. This endeavour needs 100 subjects from a single clinical site."

Answered by AI

Are there any slots still available for individuals to participate in this medical investigation?

"That is correct. In accordance with the details available on clinicaltrials.gov, this medical trial was initially posted on June 25th 2019 and most recently updated on October 31st 2022. The research requires 100 volunteers to be recruited from one site."

Answered by AI

Have past investigations focused on Midazolam yielded any pertinent results?

"Currently, 68 trials are being conducted to observe Midazolam's efficacy. 12 of them have entered Phase 3 and most studies are based in Porto Alegre, California. However, there exists a total of 727 sites conducting research with this drug."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years
Travis Nelson 2019. "Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04068948.
~6 spots leftby Apr 2025
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