Induction Methods for Children Under Anesthesia
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
Who this trial is looking for
This trial is looking for children aged 2 to 6 who are having a scheduled outpatient surgery using general anesthesia. Participants will experience different methods of anesthesia induction and will be observed for anxiety and behavior changes afterwards.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 2 to 6 years old
- I am having an outpatient elective surgery
- I will be under general anesthesia
- A parent or guardian can be with me during induction
You may not be able to join if
- I have had previous surgery
- I am afraid of the dark
- I cannot use an inhalation mask for anesthesia
- I have severe developmental delay
- I have severe preoperative anxiety
- I take psychiatric medications
- I do not speak English
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
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
Loading…
Loading trial locations…
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