Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Anxiety, Surgery

Intervention / Treatment
-----------------
* Behavioral: Virtual Parental Presence on Induction of Anesthesia
* Behavioral: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Parental Presence on Induction of Anesthesia group<br>Use of Facetime with child and parents during induction | Behavioral: Virtual Parental Presence on Induction of Anesthesia<br>* Apple Inc's FaceTime™ video application will be used when the child is taken to the operating room<br>* Other names: VPPIA;|
| Experimental: Midazolam Group<br>0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively. | Behavioral: Midazolam<br>* Preoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Anxiety in children | We will be using the modified Yale Preoperative Anxiety Scale (mYPAS) which was developed specifically to measure anxiety at anesthesia induction. It looks at activity, facial expression, alertness and arousal, vocalization and interaction with adults. It has a good validity against the State-Trait Anxiety Inventory for Children, as well as good intra and inter-observer reliability. mYPAS contains 5 items (activity, vocalisation, emotional expressivity, state of apparent arousal, and use of parent). The total score ranges from 0 to 22. Higher scores mean higher levels of anxiety. | baseline, immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction compliance | The Induction Compliance Checklist (ICC) is a validated observational scale, used to describe the compliance of a child during induction of anesthesia. ICC contains 10 items. Score ranges from 0 to 1. 0 point indicates the behavior is not observed while 1 point means behavior is observed. | immediately during anesthetic induction | 
| Change of parental anxiety | The State-Trait Anxiety Inventory (STAI) is the gold standard for assessing anxiety in adults and has been used in over 1000 studies. It is comprises 20 questions. The total score ranges from 0-63. 0-9 indicates normal or no anxiety; 10-18 indicates mild to moderate anxiety; 19-29 indicates moderate to severe anxiety; and 30-63 indicates severe anxiety. | baseline, immediately after anesthetic induction |