Clinical trial NCT05368961: Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old
Official title: Comparison of Midazolam (Versed) and Distraction on Anxiety, Emergence Delirium, Sedation/Agitation, and Vomiting in Pre-operative Patients Ages 3 to 5.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 137
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: usual care Group 2: distraction
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"
timeFrame: Pre-induction of mask anesthesia in the operating room
Secondary outcomes:
measure: Sedation/Agitation
timeFrame: Pre-induction of mask anesthesia in the operating room
measure: Number of Participants Experiencing Emergence Delirium
timeFrame: After surgery when patient woke up in the post anesthesia care unit (recovery room)
measure: Sedation/Agitation
timeFrame: After surgery at the time of admission to post anesthesia care unit (recovery room)
measure: Length of Stay (Minutes)
timeFrame: Post operative until discharged from post anesthesia care unit (recovery room)
measure: The Number of Patients Experiencing Postoperative Vomiting
timeFrame: After surgery in the post anesthesia care unit from admission to discharge
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Nancy M Albert, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.