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NCT Number: NCT05368961

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

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distraction

Behavioral

Distraction (interactive tablet)

Usual Care

Other

Anxiolytic ordered by anesthesiologist is usual care

Other names: Anxiolytic per anesthesia

Primary outcomes

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

    Time frame: 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 outcomes

  1. Sedation/Agitation

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

  2. Number of Participants Experiencing Emergence Delirium

    Time frame: 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."

  3. Sedation/Agitation

    Time frame: 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".

  4. Length of Stay (Minutes)

    Time frame: 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.

  5. The Number of Patients Experiencing Postoperative Vomiting

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Comparison of Midazolam (Versed) and Distraction on Anxiety, Emergence Delirium, Sedation/Agitation, and Vomiting in Pre-operative Patients Ages 3 to 5.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 10, 2022
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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