Shanghai Children's Hospital
Shanghai, China
NCT Number: NCT02523144
Sedation Techniques for children undergoing transthoracic echocardiography (TTE).
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Notify Me3 month–36 month
All sexes
Interventional
Phase 4
Shanghai, China
The goal in this study is to determine if there is a significant difference in the quality of sedation between two standard sedation techniques and between two doses of dexmedetomidine for children undergoing (TTE).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
70mg/kg chloral hydrate
2mcg/kg
Flavored placebo syrup
Time frame: 30 minutes
Achieve Ramsay sedation >3 within 30 minutes of administration of drug
Time frame: Patients will be followed for the duration of the procedure, average of 1 hour
Time frame: Participants will be followed for the duration of the procedure, average of 1 hour
The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted
Time frame: Participants will be followed for the duration of the procedure, 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 the hospital stay, average of 2 hours
Documentation of the incidence of respiratory complications
Time frame: Participants will be followed for the duration of the hospital stay, average of 2 hours
Documentation of 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 the post procedure stay, average of 1 hour
Documentation of the incidence of post anesthesia drowsiness
Time frame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the stay in Post Anesthesia Care Unit in minutes
Time frame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the time (in minutes) to oral fluid intake during the PACU phase
Time frame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the hospital stay after 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.
Time frame: Participants will be followed for the duration of the hospital stay, average of 2 hours
Documentation of the severity of respiratory complications
Time frame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the incidence of post anesthesia agitation
Children's Hospital Medical Center, Cincinnati
Other
A Qualitative Comparison of Oral Chloral Hydrate vs 2.0 or 3.0 mcg/kg Nasal Dexmedetomidine 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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