Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old

NeuroTherapia, Inc.

Status: Completed

Conditions: Anxiety

Treatments: Other: Usual care; Behavioral: Distraction

Study type: Interventional

Funder types: Other

Identifiers

NCT05368961

16-511

Details and patient eligibility

About

Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 3-5 year old children
• Scheduled for elective surgery
• American Society of Anesthesiologists physical status classification system: I - II

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Usual care (midazolam) is administered pre-operatively

Treatment:

Other: Usual care

Distraction

Experimental group

Description:

Distraction (interactive tablet) is given to children pre-operatively

Treatment:

Behavioral: Distraction