N/A
N=137
Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT05368961 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety" — 20; 22 Participants — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Distraction (Behavioral); Usual care (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety" |
20; 22 | 0.44 |
| SECONDARY Sedation/Agitation |
45; 48; 0; 3; 2; 1 | — |
| SECONDARY Number of Participants Experiencing Emergence Delirium |
7; 8 | — |
| SECONDARY Sedation/Agitation |
45; 48; 0; 3; 2; 1 | — |
| SECONDARY Length of Stay (Minutes) |
88.0; 75.5 | — |
| SECONDARY The Number of Patients Experiencing Postoperative Vomiting |
1; 2 | — |
Summary
Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in 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
Data sourced from ClinicalTrials.gov (NCT05368961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.