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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368961
• Other study ID #: 16-511
• Status: Completed
• Phase: N/A
• Start date: April 7, 2017
• Est. completion date: March 8, 2019

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Distraction
Distraction (interactive tablet)

Other:
• Usual care
Anxiolytic ordered by anesthesiologist is usual care

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97. — View Citation

Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17. — View Citation

Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Pre-induction of mask anesthesia in the operating room
Secondary	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".	Pre-induction of mask anesthesia in the operating room
Secondary	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."	After surgery when patient woke up in the post anesthesia care unit (recovery room)
Secondary	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".	After surgery at the time of admission to post anesthesia care unit (recovery room)
Secondary	Length of Stay (Minutes)	Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit.	Post operative until discharged from post anesthesia care unit (recovery room)
Secondary	The Number of Patients Experiencing Postoperative Vomiting	The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged).	After surgery in the post anesthesia care unit from admission to discharge