Trial · NCT02250820
A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
NCT02250820, Phase 1, Completed, Children's Hospital Medical Center, Cincinnati
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE). Trials, record NCT02250820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02250820
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
- NCT number
- NCT02250820
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 280 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Heart Disease
- Interventions
- Dexmedetomidine, Pentobarbital, Oral Placebo, Nasal Placebo
- First posted
- 2014-09-26
- Last updated
- 2020-01-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sedation Quality | 60 minutes | 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 | Time to sedation | Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes | Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level \>3. |
| Secondary | Delirium prior to sedation | Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes | The incidence of delirium prior to achieving sedation. |
| Secondary | Duration of sedation level >3 | Participants will be followed for the duration of the procedure, an expected average of 1 hour | |
| Secondary | Sonographer Pauses | Participants will be followed for the duration of the procedure, an expected average of 1 hour | The number of sonographer pauses over 2 minutes due to patient movement or medical intervention will be counted. |
| Secondary | Need for rescue nasal Dexmedetomidine | Participants will be followed for the duration of the procedure, an expected average of 1 hour | The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE. |
| Secondary | Incidence-severity of respiratory complications | Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours | We will document the incidence and severity of respiratory complications (including supplemental oxygen). |
| Secondary | Vital sign deviations of more than 30% from baseline | Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours | 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. |
| Secondary | Post anesthesia drowsiness or agitation | Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour | We will document the incidence-severity of post anesthesia drowsiness or agitation. |
| Secondary | Duration of Post Anesthesia Care Unit (PACU) Phase | Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour | We will document the duration of stay in Post Anesthesia Care Unit (PACU) phase in minutes. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29369091 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02250820
GET https://conductscience.org/api/trials/v1/NCT02250820/registered