Induction in the Dark

Conditions

• Anesthesia Induction

Eligibility Criteria

Sex

ALL

Age

2 Years - 6 Years

Healthy Volunteers

Not accepted

Interventions

• Dark with star projector — OTHER
  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 — DRUG
  Midazolam by mouth preoperatively.
• Parental Presence — OTHER
  A parent or guardian will accompany the child into the OR and be present for the start of induction.

Study Details

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.

Key Dates

Start date

Apr 16, 2024

Status verified

Jul 2025

Primary completion

Jun 15, 2026

Completion

Jun 22, 2026

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

• Haley Nitchie, MHA
  843-792-1869
  [email protected]

Locations (1)

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