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

The Cleveland Clinic137 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

137

Conditions

Anxiety

Interventions

DistractionBEHAVIORAL

Distraction (interactive tablet)

Usual careOTHER

Anxiolytic ordered by anesthesiologist is usual care

Eligibility

Sex: ALLMin age: 3 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"

Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".

Time frame: Pre-induction of mask anesthesia in the operating room

Secondary Outcomes

Sedation/Agitation

Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".

Time frame: Pre-induction of mask anesthesia in the operating room

Number of Participants Experiencing Emergence Delirium

Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool. The scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of "emergence delirium."

Time frame: After surgery when patient woke up in the post anesthesia care unit (recovery room)

Sedation/Agitation

Time frame: After surgery at the time of admission to post anesthesia care unit (recovery room)

Data from ClinicalTrials.gov

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