Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam (NCT05834049) | Clinical Trial Compass
WithdrawnNot Applicable
Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam
Stopped: The collaborator has no intention to initiate the study at this moment.
0Started 2025-07-01
Plain-language 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.
Who can participate
Age range
4 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of Anxiety in children
Timeframe: baseline, immediately after the intervention