Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

Stanford University

Status: Not yet enrolling

Conditions: Surgery; Anxiety

Treatments: Behavioral: Virtual Parental Presence on Induction of Anesthesia; Behavioral: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05834049

69571

Details and patient eligibility

About

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.

Enrollment: 322 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children from ages 4 years to 8 years old undergoing outpatient surgery
• children identified as needing premedication
• ASA physical status I, II or III
• planned inhalational induction
• children presenting from home prior to surgery (not an inpatient)
• English speaking parents and child

Exclusion criteria

• children with developmental delay
• children with psychological / emotional disorders
• children with altered mental status
• children in whom midazolam may be medically contraindicated per the discretion of the anesthesia care team
• children with language barrier
• children who are not accompanied by someone able to consent (ie legal guardian)
• children who are inpatient prior to surgery
• children with expected difficult intubation/airway
• children presenting for emergency surgery
• family history or personal history of malignant hyperthermia / risk of MH
• consent not obtained or withdrawal of consent
• children with past history of violent behaviors during induction of anesthesia
• cancellation of surgery
• patients with a diagnosis of COVID-19 or a patient under investigation for COVID-19, including patients being treated with airborne precautions in the operating room
• receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) ketamine, and/or dexmedetomidine.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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322 participants in 2 patient groups

Virtual Parental Presence on Induction of Anesthesia group

Experimental group

Description:

Use of Facetime with child and parents during induction

Treatment:

Behavioral: Virtual Parental Presence on Induction of Anesthesia

Midazolam Group

Experimental group

Description:

0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively.

Treatment:

Behavioral: Midazolam