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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Dexmedetomidine and oral placebo | Experimental | If the patient is assigned to the dexmedetomidine arm, they will receive dexmedetomidine through the nose. In order to keep the assignment blinded, the patient will also receive an oral placebo. |
|
| Nasal placebo and oral pentobarbital | Experimental | If the patient is assigned to the pentobarbital arm, they will receive pentobarbital through the mouth. In order to keep the assignment blinded, the patient will also receive an nasal placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Nasal administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sedation | Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level >3. | Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes |
| Delirium prior to sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Miller, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29369091 | Derived | Miller JW, Ding L, Gunter JB, Lam JE, Lin EP, Paquin JR, Li BL, Spaeth JP, Kreeger RN, Divanovic A, Mahmoud M, Loepke AW. Comparison of Intranasal Dexmedetomidine and Oral Pentobarbital Sedation for Transthoracic Echocardiography in Infants and Toddlers: A Prospective, Randomized, Double-Blind Trial. Anesth Analg. 2018 Jun;126(6):2009-2016. doi: 10.1213/ANE.0000000000002791. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D010424 | Pentobarbital |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Pentobarbital |
| Drug |
Oral administration |
|
| Oral Placebo | Other | Oral placebo will be cherry syrup |
|
|
| Nasal Placebo | Other | Nasal placebo will be nasally atomized saline |
|
|
The incidence of delirium prior to achieving sedation. |
| 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 | 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. | 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. | Participants will be followed for the duration of the procedure, an expected average of 1 hour |
| Incidence-severity of respiratory complications | We will document the incidence and severity of respiratory complications (including supplemental oxygen). | 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. | 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. | 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. | 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 | 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. | 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. | up to 3 days |
| D001463 |
| Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |