drugset
drugset / Trial / NCT05126459

A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients

NCT05126459 ↗

Phase 3 Completed 60 enrolled Loma Linda University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare the post sedation events from three different multi-drug oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients and prepare parents appropriately and caution them about the expected effects. Patients will be evaluated for adverse effects within two time periods at 8 and 24 hours post oral sedation procedure using surveys.

Timeline

Start
2022-02-14
Primary completion
2023-04-11
Completion
2023-04-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Meperidine Unknown 1.5 mg/kg Oral
Subject Meperidine Unknown 2 mg/kg Oral
Subject Midazolam Small molecule 0.5 mg/kg Oral
Subject Midazolam Small molecule 0.75 mg/kg Oral
Background Hydroxyzine Small molecule 1.5 mg/kg Oral
Background Hydroxyzine Small molecule 2 mg/kg Oral
Background Nitrous Oxide Other / unclassified 30 % Inhaled
Background Nitrous Oxide Other / unclassified 50 % Inhaled
Background Oxygen Other / unclassified 50 % Inhaled
Background Oxygen Other / unclassified 70 % Inhaled

Indications

anxiety dental caries