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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Usual care; Behavioral: Distraction

• Registration Number: NCT05368961
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2017-04-07
• Primary Completion: 2019-03-08
• Study Completion: 2019-03-08
• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Results First Submitted: 2022-08-17
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Results First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Usual care (midazolam) is administered pre-operatively
Distraction	Distraction	Distraction (interactive tablet) is given to children pre-operatively

Primary Outcome Measures

Name	Time	Method
mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"	Pre-induction of mask anesthesia in the operating room	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".

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Emergence Delirium	After surgery when patient woke up in the post anesthesia care unit (recovery room)	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."
Length of Stay (Minutes)	Post operative until discharged from post anesthesia care unit (recovery room)	Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit.
The Number of Patients Experiencing Postoperative Vomiting	After surgery in the post anesthesia care unit from admission to discharge	The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged).
Sedation/Agitation	After surgery at the time of admission to post anesthesia care unit (recovery room)	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".

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States