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Heart DiseasePhase 1NCT02250820

A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)

A Phase 1 study testing Dexmedetomidine and Pentobarbital in people with Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 24 months
Conditions the study is for
Heart Disease
What is being tested?
Dexmedetomidine and Pentobarbital
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
280 participants
Where
1 siteUnited States
Study dates
Nov 2014to Dec 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography

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).

Read the 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.

Conditions
Heart Disease
Being tested
Dexmedetomidine, Pentobarbital, Oral Placebo, Nasal Placebo
Keywords
Pediatric, Sedation, Transthoracic echocardiography, TTE, Dexmedetomidine, Pentobarbital
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Nasal administration

  • PentobarbitalDrug

    Oral administration

  • Oral PlaceboOther

    Also called Cherry Syrup

    Oral placebo will be cherry syrup

  • Nasal PlaceboOther

    Also called Nasally atomized saline

    Nasal placebo will be nasally atomized saline

Study groups in NCT02250820
Study groupRoleWhat they receive
Nasal Dexmedetomidine and oral placeboExperimentalIf 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.
Receives: Drug: Dexmedetomidine; Other: Oral Placebo
Nasal placebo and oral pentobarbitalExperimentalIf 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.
Receives: Drug: Pentobarbital; Other: Nasal Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 60 minutes

Secondary outcomes (12)

  1. Time to sedation

    Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level >3.

    Measured: Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes

  2. Delirium prior to sedation

    The incidence of delirium prior to achieving sedation.

    Measured: Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes

  3. Duration of sedation level >3

    Measured: Participants will be followed for the duration of the procedure, an expected average of 1 hour

  4. Sonographer Pauses

    The number of sonographer pauses over 2 minutes due to patient movement or medical intervention will be counted.

    Measured: Participants will be followed for the duration of the procedure, an expected average of 1 hour

  5. Need for rescue nasal Dexmedetomidine

    The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.

    Measured: Participants will be followed for the duration of the procedure, an expected average of 1 hour

  6. Incidence-severity of respiratory complications

    We will document the incidence and severity of respiratory complications (including supplemental oxygen).

    Measured: Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours

  7. 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.

    Measured: Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours

  8. Post anesthesia drowsiness or agitation

    We will document the incidence-severity of post anesthesia drowsiness or agitation.

    Measured: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour

  9. Duration of Post Anesthesia Care Unit (PACU) Phase

    We will document the duration of stay in Post Anesthesia Care Unit (PACU) phase in minutes.

    Measured: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour

  10. Time to oral fluid intake

    We will document the time (in minutes) to oral fluid intake during the PACU phase

    Measured: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour

  11. Time to discharge

    We will document the time it takes a patient to be discharged from the hospital after the completion of the TTE.

    Measured: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour

  12. 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.

    Measured: up to 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02250820
Sponsor's protocol ID
2014-5961
Status last verified
Jan 2020
First submitted
16 Sep 2014
Last updated
21 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29369091

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexmedetomidine and Pentobarbital in people with Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedation Quality (time frame: 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02250820, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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