RECRUITINGPhase 4INTERVENTIONAL

Induction in the Dark

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

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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