Status:
COMPLETED
Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old
Lead Sponsor:
The Cleveland Clinic
Conditions:
Anxiety
Eligibility:
All Genders
3-5 years
Phase:
NA
Brief Summary
Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old
Detailed Description
Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.
Eligibility Criteria
Inclusion
- 3-5 year old children
- Scheduled for elective surgery
- American Society of Anesthesiologists physical status classification system: I - II
Exclusion
- Children younger than 3 or older than 6
- Allergy to midazolam
- Cognitive or developmental delays
- American Society of Anesthesiologists physical status classification system: III - VI
- Anesthesia provider determines child is not eligible
- Children that are transferred to ICU after surgery
Key Trial Info
Start Date :
April 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2019
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT05368961
Start Date
April 7 2017
End Date
March 8 2019
Last Update
April 1 2024
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195