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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: Completed Phase 4 study of Dental Caries in Children and Midazolam, sponsored by University of Washington.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Children's behavior during sedation is rated on the Houpt Behavior Rating Scale. A successful sedation is rated as Excellent, Very Good, or Good. A failed sedation is rated as Fair, Poor, or Aborted.
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 |
What the finished NCT04068948 record still lists
NCT04068948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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
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Where NCT04068948's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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