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NCT06144177 | RECRUITING | Anesthesia Induction

Induction in the Dark
Sponsor:

Medical University of South Carolina

Information provided by (Responsible Party):

Natalie Barnett

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.

Condition or disease

Anesthesia Induction

Intervention/treatment

Dark with star projector

Preoperative midazolam

Parental Presence

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety
Actual Study Start Date : 2024-04-16
Estimated Primary Completion Date : 2025-06-15
Estimated Study Completion Date : 2025-06-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years to 6 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • Induction in the Dark

    Location Details

    NCT06144177

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    How to Participate

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    Locations

    RECRUITING

    United States, South Carolina

    Medical University of South Carolina

    Charleston, South Carolina, United States, 29425