Recruiting

Midazolam, Parental Presence

Sponsor:

Medical University of South Carolina

Code:

NCT06144177

Conditions

Anesthesia Induction

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Interventions

Dark with star projector

Preoperative midazolam

Parental Presence

Study Details

Brief 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.

Conditions

Anesthesia Induction

Study ID

NCT06144177

Start date

Apr 16, 2024

Status verified date

Jun, 2026

Completion date

May 22, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Darkened room and star projector with parental presence

Subjects assigned to this arm, 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. They will also have a parent in the room with them during induction of anesthesia.

active comparator: Preoperative midazolam 0.5 mg/kg po and parental presence

Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia.

active comparator: Parental presence alone

Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia.

Interventions

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.

Preoperative midazolam

Midazolam by mouth preoperatively.

Parental Presence

A parent or guardian will accompany the child into the OR and be present for the start of induction.

Primary outcome measure

  • Mask acceptance [ Time Frame: during induction evaluated up until the start of the scheduled surgery ]

Central Contacts and Locations

Central contacts

Haley Nitchie, MHA

843-792-1869nitchie@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Haley Nitchie, MHA

843-792-1869nitchie@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-06-22.