Induction in the Dark
ConditionAnesthesia Induction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-6
SponsorMedical University of South Carolina
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 parental presence; or 3. parental presence alone.
Eligibility criteria
Qualifiers
Age 2 to 6 years old
American Society of Anesthesiologists physical status I-II
Outpatient elective surgical procedures
Undergoing general anesthesia
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dark with star projector
- Preoperative midazolam
- Parental Presence
Treatment groups
240 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov