Induction in the Dark
Recruiting
Phase 4
Interventional Study
Anesthesia Induction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 6
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 240 (estimated)
- Sponsor
- Medical University of South Carolina · Other
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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 paren…
Trial Locations
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Eligibility 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 t…
Contacts