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Sedation Techniques for children undergoing transthoracic echocardiography (TTE).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloral Hydrate + placebo | Active Comparator | Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo |
|
| Dexmedetomidine 2mcg/kg + placebo | Active Comparator | Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo |
|
| Dexmedetomidine 3mcg/kg + placebo | Active Comparator | Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloral Hydrate | Drug | 70mg/kg chloral hydrate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sedation | Achieve Ramsay sedation >3 within 30 minutes of administration of drug | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of sedation level >3 | Patients will be followed for the duration of the procedure, average of 1 hour | |
| The number of sonographer pauses | The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Miller, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children's Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002697 | Chloral Hydrate |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Dexmedetomidine |
| Drug |
2mcg/kg |
|
| Dexmedetomidine | Drug | 3mcg/kg |
|
| Placebo | Drug | Flavored placebo syrup |
|
| Participants will be followed for the duration of the procedure, average of 1 hour |
| Need for rescue dexmedetomidine | The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE. | Participants will be followed for the duration of the procedure, average of 1 hour |
| Incidence of respiratory complications | Documentation of the incidence of respiratory complications | Participants will be followed for the duration of the hospital stay, average of 2 hours |
| Vital sign deviations of more than 30% from baseline | 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. | Participants will be followed for the duration of the hospital stay, average of 2 hours |
| Post anesthesia drowsiness | Documentation of the incidence of post anesthesia drowsiness | Participants will be followed for the duration of the post procedure stay, average of 1 hour |
| Duration of Post Anesthesia Care Unit phase | Documentation of the stay in Post Anesthesia Care Unit in minutes | Participants will be followed for the duration of the post procedure stay, average of 1 hour |
| Time to oral fluid intake | Documentation of the time (in minutes) to oral fluid intake during the PACU phase | Participants will be followed for the duration of the post procedure stay, average of 1 hour |
| Time to discharge | Documentation of the hospital stay after completion of the TTE. | Participants will be followed for the duration of the post procedure stay, average of 1 hour |
| Satisfaction of 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. | Up to 3 days |
| Severity of respiratory complications | Documentation of the severity of respiratory complications | Participants will be followed for the duration of the hospital stay, average of 2 hours |
| Post anesthesia agitation | Documentation of the incidence of post anesthesia agitation | Participants will be followed for the duration of the post procedure stay, average of 1 hour |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |