Back to resultsA Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
Primary Purpose
Heart Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Pentobarbital
Oral Placebo
Nasal Placebo
Sponsored by
About this trial
This is an interventional other trial for Heart Disease focused on measuring Pediatric, Sedation, Transthoracic echocardiography, TTE, Dexmedetomidine, Pentobarbital
Eligibility Criteria
Inclusion Criteria:
- Outpatients, scheduled to receive sedation for elective transthoracic echocardiography
- The subject must be a candidate for both anesthetic techniques. A staff member of the Division of Cardiac Anesthesiology will make this decision.
- The subjects must be 3 months to 24 months (inclusive of the 24th month).
- The subject's legally authorized representative has given written informed consent to participate in the study.
Exclusion Criteria:
- The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree Atrioventricular block) or channelopathy (e.g. long QT syndrome).
- The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or vasodilators (e.g. ACE inhibitors) on the day of the study procedures. It is routine for children taking these medications to hold them on the day of their procedure, as requested by the clinical team.
- The subject has received a dose of any other sedative within 48 hours.
- The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
- The subject is allergic to or has a contraindication to any of the drugs or masking flavored syrup used in the study.
- The subject has previously been treated under this protocol.
- The subject has Trisomy 21 (exaggerated risk of bradycardia)
- The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)
- The subject has Moyamoya disease (risk of recurrent stroke)
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nasal Dexmedetomidine and oral placebo
Nasal placebo and oral pentobarbital
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to sedation
Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level >3.
Delirium prior to sedation
The incidence of delirium prior to achieving sedation.
Duration of sedation level >3
Sonographer Pauses
The number of sonographer pauses over 2 minutes due to patient movement or medical intervention will be counted.
Need for rescue nasal Dexmedetomidine
The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
Incidence-severity of respiratory complications
We will document the incidence and severity of respiratory complications (including supplemental oxygen).
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.
Post anesthesia drowsiness or agitation
We will document the incidence-severity of post anesthesia drowsiness or agitation.
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 to oral fluid intake
We will document the time (in minutes) to oral fluid intake during the PACU phase
Time to discharge
We will document the time it takes a patient to be discharged from the hospital after the completion of the TTE.
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.
Full Information
NCT ID
NCT02250820
First Posted
September 16, 2014
Last Updated
January 17, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02250820
Brief Title
A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
Official Title
A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
Pediatric, Sedation, Transthoracic echocardiography, TTE, Dexmedetomidine, Pentobarbital
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal Dexmedetomidine and oral placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Nasal placebo and oral pentobarbital
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Nasal administration
Intervention Type
Drug
Intervention Name(s)
Pentobarbital
Intervention Description
Oral administration
Intervention Type
Other
Intervention Name(s)
Oral Placebo
Other Intervention Name(s)
Cherry Syrup
Intervention Description
Oral placebo will be cherry syrup
Intervention Type
Other
Intervention Name(s)
Nasal Placebo
Other Intervention Name(s)
Nasally atomized saline
Intervention Description
Nasal placebo will be nasally atomized saline
Primary Outcome Measure Information:
Title
Sedation Quality
Description
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
Secondary Outcome Measure Information:
Title
Time to sedation
Description
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
Title
Delirium prior to sedation
Description
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
Title
Duration of sedation level >3
Time Frame
Participants will be followed for the duration of the procedure, an expected average of 1 hour
Title
Sonographer Pauses
Description
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
Title
Need for rescue nasal Dexmedetomidine
Description
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
Title
Incidence-severity of respiratory complications
Description
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
Title
Vital sign deviations of more than 30% from baseline
Description
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
Title
Post anesthesia drowsiness or agitation
Description
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
Title
Duration of Post Anesthesia Care Unit (PACU) Phase
Description
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
Title
Time to oral fluid intake
Description
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
Title
Time to discharge
Description
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
Title
Satisfaction of the Parents
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients, scheduled to receive sedation for elective transthoracic echocardiography
The subject must be a candidate for both anesthetic techniques. A staff member of the Division of Cardiac Anesthesiology will make this decision.
The subjects must be 3 months to 24 months (inclusive of the 24th month).
The subject's legally authorized representative has given written informed consent to participate in the study.
Exclusion Criteria:
The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree Atrioventricular block) or channelopathy (e.g. long QT syndrome).
The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or vasodilators (e.g. ACE inhibitors) on the day of the study procedures. It is routine for children taking these medications to hold them on the day of their procedure, as requested by the clinical team.
The subject has received a dose of any other sedative within 48 hours.
The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
The subject is allergic to or has a contraindication to any of the drugs or masking flavored syrup used in the study.
The subject has previously been treated under this protocol.
The subject has Trisomy 21 (exaggerated risk of bradycardia)
The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)
The subject has Moyamoya disease (risk of recurrent stroke)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Miller, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29369091
Citation
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.
Results Reference
derived
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A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
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