Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam
NCT ID: NCT05834049
Last Updated: 2024-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
322 participants
INTERVENTIONAL
2025-07-01
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Virtual Parental Presence on Induction of Anesthesia group
Use of Facetime with child and parents during induction
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
Midazolam Group
0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively.
Midazolam
Preoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated.
Interventions
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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
Midazolam
Preoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
4 Years
8 Years
ALL
No
Sponsors
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Nationwide Children's Hospital
OTHER
Stanford University
OTHER
Responsible Party
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Thomas Caruso
Clinical Professor
Principal Investigators
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Vanessa Olbrecht, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Central Contacts
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Other Identifiers
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69571
Identifier Type: -
Identifier Source: org_study_id
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