drugset / Trial / NCT04068948

Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years

NCT04068948

Phase 4 Completed 37 enrolled University of Washington
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-06-25
Primary completion
2022-12-31
Completion
2023-01-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Meperidine Unknown 1.5 mg/kg Oral
Background Hydroxyzine Small molecule 1 mg/kg Oral
Background Midazolam Small molecule 0.5 mg/kg Oral

Indications