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Induction in the Dark

RecruitingPhase 4Ages 2 Years - 6 YearsAllMedical University of South Carolina
NCT06144177 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Dark with star projector
  • Preoperative midazolam
  • Parental Presence
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Where

1 site
Medical University of South Carolina
Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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