drugset / Trial / NCT06144177

Induction in the Dark

NCT06144177 ↗

Phase 4 Recruiting 240 enrolled Medical University of South Carolina
RandomizedParallel-groupOpen-labelPrevention

Summary

This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week. 1. darkened room and star projector with parental presence; 2. preoperative midazolam 0.5 mg/kg by mouth and parental presence; or 3. parental presence alone.

Timeline

Start
2024-04-16
Primary completion
2027-04-15
Completion
2027-05-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.5 mg/kg Oral

Indications

No indication recorded.