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 range4 Years – 8 Years
SexALL
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.
What they're measuring
1
Change of Anxiety in children
Timeframe: baseline, immediately after the intervention