NCT06144177PHASE4Recruiting

Induction in the Dark

Medical University of South Carolina

Start Date

4/16/2024

Completion Date

5/22/2027

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

Age Range: 2 years to 6 years

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

Interventions

OTHER

Dark with star projector

DRUG

Preoperative midazolam

OTHER

Parental Presence

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Anesthesia Induction

Locations

Medical University of South Carolina

Charleston, South Carolina 29425

United States