Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04068948 · ClinicalTrials.gov registry record · Phase 4
Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years
A Phase 4 study of Dental Caries in Children and Midazolam, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT04068948 is a Phase 4 study of Dental Caries in Children and Midazolam that has completed, run by University of Washington. The registered enrollment target is 37 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04068948, a Phase 4 study of Dental Caries in Children and Midazolam, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this randomized controlled trial is to assess the effects of oral sedation using midazolam and hydroxyzine with and without meperidine (a narcotic) on sedation outcomes in pediatric dental patients undergoing dental treatment at the University of Washington Center for Pediatric Dentistry. Procedural sedation can be offered as an option for dental treatment for a young, potentially uncooperative pediatric patient to safely and effectively complete dental restorative needs. Both sedation regimens are already regularly used for patients at the UW CPD. The goal of this study is to assess if removing a narcotic from the regimen will produce the same behavioral success outcomes as a regimen with a narcotic. Our hypothesis is that patients who receive oral sedation using midazolam, hydroxyzine, and meperidine will experience fewer behavioral failures than those who receive oral sedation using midazolam and hydroxyzine without meperidine. The secondary objective of this project is to evaluate the relationship between child temperament and sedation outcome in each treatment group.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Meperidine
- DRUG Hydroxyzine
Study Locations (1)
Washington
- University of Washington Center for Pediatric Dentistry - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2023-01-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04068948
The ClinicalTrials.gov registry entry for NCT04068948 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Dental Caries in Children appearing as the primary indexed condition, and to 3 interventions - of which Midazolam is the first listed.
NCT04068948 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT04068948 about?
NCT04068948 is a clinical study titled "Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years". The primary objective of this randomized controlled trial is to assess the effects of oral sedation using midazolam and hydroxyzine with and without meperidine (a narcotic) on sedation outcomes in pediatric dental patients undergoing dental treatment at the University of Washington Center for Pediat...
What is the current status of trial NCT04068948?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2019-06-25. Estimated completion is 2023-01-31.
What conditions does trial NCT04068948 study?
This clinical trial studies the following conditions: Dental Caries in Children, Midazolam, Pediatric Dental Sedation, Meperidine, Hydroxyzine.
What interventions are being tested in trial NCT04068948?
The interventions under investigation include: Midazolam (DRUG), Meperidine (DRUG), Hydroxyzine (DRUG).
Who is sponsoring clinical trial NCT04068948?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04068948 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dental Caries in Children
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.