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RECRUITING
NCT06144177
PHASE4

Induction in the Dark

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-04-16

Completion Date

2026-06-22

Last Updated

2025-07-08

Healthy Volunteers

No

Interventions

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States