CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Regimen 1 +2 morecombination
Likely dose
Regimen 1 2mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05126459
NCT05126459Phase 3Completed

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

Loma Linda University·interventional·Posted Nov 19, 2021·Updated Oct 2, 2024

In Brief

A Phase 3 clinical trial evaluating Regimen 1, Regimen #2, and 1 other intervention for Anxiety, Dental and Dental Decay. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedNov 19, 2021
Enrollment StartFeb 14, 2022
Primary CompletionApr 11, 2023
Study CompletionApr 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.6 years ago

Interventions

Regimen 1combination

Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.

Regimen #2combination

Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.

Regimen #3combination

Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.