Induction in the Dark

Last updated: July 7, 2025
Sponsor: Medical University of South Carolina
Overall Status: Active - Recruiting

Phase

4

Condition

Anesthesia

Treatment

Preoperative midazolam

Dark with star projector

Parental Presence

Clinical Study ID

NCT06144177
Pro00132312
  • Ages 2-6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Preoperative midazolam
Phase: 4
Study Start date:
April 16, 2024
Estimated Completion Date:
June 22, 2026

Connect with a study center

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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