NCT06144177

Induction in the Dark

Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia Induction

Interventions

Type	Name	Description
OTHER	Dark with star projector	When in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on.
DRUG	Preoperative midazolam	Midazolam by mouth preoperatively.
OTHER	Parental Presence	A parent or guardian will accompany the child into the OR and be present for the start of induction.

Timeline

• Start date: 2024-04-16
• Primary completion: 2026-06-15
• Completion: 2026-06-22
• First posted: 2023-11-22
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study