Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT02250820
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).
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Notify Me3 month–24 month
All sexes
Interventional
Phase 1
Cincinnati, Ohio, 45229, United States
Currently there are two sedation methods used for children less than 24 months of age undergoing transthoracic echocardiography (TTE).
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nasal administration
Oral administration
Oral placebo will be cherry syrup
Other names: Cherry Syrup
Nasal placebo will be nasally atomized saline
Other names: Nasally atomized saline
Time frame: 60 minutes
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: Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes
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
The incidence of delirium prior to achieving sedation.
Time frame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
Time frame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
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
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 their outpatient hospital stay, an expected average of 2 hours
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
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 post procedure stay, an expected average of 1 hour
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
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
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
We will document the time it takes a patient to be discharged from the hospital after the completion of the TTE.
Time frame: up to 3 days
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.
Children's Hospital Medical Center, Cincinnati
Other
A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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