NCT05834049

Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

Virtual Parental Presence on Induction of Anesthesia Versus Premedication With Midazolam: A Non-Inferiority Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.

Conditions

• Anxiety
• Surgery

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Parental Presence on Induction of Anesthesia	Apple Inc's FaceTime™ video application will be used when the child is taken to the operating room
BEHAVIORAL	Midazolam	Preoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-31
• Completion: 2027-12-30
• First posted: 2023-04-28
• Last updated: 2024-02-15