The study will examine the quality of two sedation techniques (dexmedetomidine and pentobarbital) used for children aged 3 to 24 months who are undergoing a transthoracic echocardiography (TTE).
Currently there are two sedation methods used for children less than 24 months of age undergoing transthoracic echocardiography (TTE). * One method provides sedation by mouth with the drug pentobarbital, * The other provides sedation through the nose with the drug dexmedetomidine. The choice of which method is used is based on evaluation of the patient's medical history and the preference of the anesthesiologist. To our knowledge, no study has compared these two sedation techniques for quality of care. The proposed study will help us determine which method yields the best quality and will allow us to improve the healthcare experience of our patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
280
Nasal administration
Oral administration
Oral placebo will be cherry syrup
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Sedation Quality
The primary outcome variable will be the sedation quality for the first 60 minutes after sedation drug is administered. It will be assessed if child is sedated within 30 minutes of administration of sedative drug, and if sedation is maintained for at least 30 minutes to allow a detailed transthoracic echocardiographic study. Sedation is defined as achieving Ramsay sedation level \>3.
Time frame: 60 minutes
Time to sedation
Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level \>3.
Time frame: Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes
Delirium prior to sedation
The incidence of delirium prior to achieving sedation.
Time frame: Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes
Duration of sedation level >3
Time frame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
Sonographer Pauses
The number of sonographer pauses over 2 minutes due to patient movement or medical intervention will be counted.
Time frame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
Need for rescue nasal Dexmedetomidine
The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
Time frame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Nasal placebo will be nasally atomized saline
Incidence-severity of respiratory complications
We will document the incidence and severity of respiratory complications (including supplemental oxygen).
Time frame: Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours
Vital sign deviations of more than 30% from baseline
We will document the incidence of blood pressure or heart rate deviations of more than 30% from baseline. Baseline will be measured prior to sedative administration.
Time frame: Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours
Post anesthesia drowsiness or agitation
We will document the incidence-severity of post anesthesia drowsiness or agitation.
Time frame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
Duration of Post Anesthesia Care Unit (PACU) Phase
We will document the duration of stay in Post Anesthesia Care Unit (PACU) phase in minutes.
Time frame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
Time to oral fluid intake
We will document the time (in minutes) to oral fluid intake during the PACU phase
Time frame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
Time to discharge
We will document the time it takes a patient to be discharged from the hospital after the completion of the TTE.
Time frame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
Satisfaction of the Parents
The satisfaction of the sedation technique will be completed by the parents by asking a series of questions during a follow-up phone call the next business day after the TTE.
Time frame: up to 3 days