Induction in the Dark

• Status: Recruiting
• Trial end date: 2025-06-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Midazolam

Criteria

Inclusion Criteria

• Age 2 to 6 years old

• American Society of Anesthesiologists physical status I-II

• Outpatient elective surgical procedures

• Undergoing general anesthesia

• Parent or guardian willing to be present during induction

Exclusion Criteria

• History of previous surgery

• Fear of the dark

• Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.

• Severe developmental delay

• Severe obvious, preoperative anxiety

• Patients currently using psychiatric medications

• Non-English speaking