Trial · NCT03417999

Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease

NCT03417999, Phase 1, Terminated, Children's Hospital of Philadelphia; results first posted 2024-03-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease. Trials, record NCT03417999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03417999

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
NCT number: NCT03417999
Status: Terminated
Phases: Phase 1
Enrollment: 28 participants, actual
Lead sponsor: Children's Hospital of Philadelphia
Conditions: Dexmedetomidine, Congenital Heart Disease
Interventions: Dexmedetomidine
First posted: 2018-01-31
Last updated: 2024-03-22
Results first posted: 2024-03-22
Limitations and caveats: 1. Unable to enroll subjects in Cohort 1B to determine if DEX PK is different in patients spontaneously ventilating with a natural airway versus mechanically ventilated via oral endotracheal tube.~2. Unable to sample long enough to determine elimination phase of IN DEX.~3. Small sample size and heterogenous population limit interpretation of results.~4. COVID delayed enrollment and loss of research personnel.~5. PI left institution prior to completion of study and so study was terminated.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Samples Obtained Per Subject	Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration	Following the administration of atomized intranasal dexmedetomidine, serum samples will be drawn at 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes post drug administration. This is the number of samples obtained per subject.
Primary	Time of Peak Drug Concentration Level of Dexmedetomidine	Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration	Following the administration of atomized intranasal dexmedetomidine, serum samples will be drawn at 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes post drug administration. The time of peak drug concentration will be determined based on this data.
Primary	Serum Drug Concentration Levels of Dexmedetomidine	Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration	Following administration of atomized intranasal dexmedetomidine, serum samples will be obtained at the following times post administrations: 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes. Peak concentration will be determined based on this data.
Primary	Dose-limiting Toxicities (DLT) and/or Maximum Plasma Level > 1000 pg/mL	Subjects were monitored for 6 hours after the administration of study drug.	Dose-limiting toxicities (DLT) include bradycardia, hypotension, new intraventricular conduction abnormality or any serious adverse event possibly, probably, or definitely related to intranasal dexmedetomidine administration that occured after the administration of the intranasal dexmedetomidine and through the completion of PK sampling. Bradycardia, hypotension, or new intraventricular conduction abnormalities that occured after the administration of intravenous dexmedetomidine given by the primary anesthesia team as part of usual clinical care were not considered DLTs but were considered an adverse event. Any events that could not be explained by the intervention that the patient was undergoing were assumed to be related to the study drug.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Samples Obtained Per Subject	Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration	Population includes all subjects who received study drug. This included evaluable and non-evaluable subjects.	Samples	MEDIAN
PRIMARY	Time of Peak Drug Concentration Level of Dexmedetomidine	Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration	Analysis population includes subjects who received study drug and had at least 90 minutes of sampling time to ensure that Tmax had been achieved. There was one subject in Cohort 1a who had BLQ for all samples obtained for unknown reasons. This subject's data also not be evaluated.	minutes	MEDIAN
PRIMARY	Serum Drug Concentration Levels of Dexmedetomidine	Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration	Analysis population includes subjects who received study drug and had at least 90 minutes of sampling time to ensure that Cmax had been achieved. There was one subject in Cohort 1a who had BLQ for all samples obtained for unknown reasons. This subject's data could also not be evaluated.	pg/mL	MEDIAN
PRIMARY	Dose-limiting Toxicities (DLT) and/or Maximum Plasma Level > 1000 pg/mL	Subjects were monitored for 6 hours after the administration of study drug.	Population includes any subject who received study drug	Events	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Samples Obtained Per Subject	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	10	Inter-Quartile Range 9 to 10	Samples
Number of Samples Obtained Per Subject	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	9	Inter-Quartile Range 7 to 9	Samples
Number of Samples Obtained Per Subject	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	10	Inter-Quartile Range 6.5 to 10	Samples
Time of Peak Drug Concentration Level of Dexmedetomidine	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	91	Inter-Quartile Range 44 to 120	minutes
Time of Peak Drug Concentration Level of Dexmedetomidine	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	30	Inter-Quartile Range 15 to 31	minutes
Time of Peak Drug Concentration Level of Dexmedetomidine	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	54	Inter-Quartile Range 45 to 106	minutes
Serum Drug Concentration Levels of Dexmedetomidine	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	413	Inter-Quartile Range 311 to 565	pg/mL
Serum Drug Concentration Levels of Dexmedetomidine	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	570	Inter-Quartile Range 315 to 679	pg/mL
Serum Drug Concentration Levels of Dexmedetomidine	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	1000	Inter-Quartile Range 978 to 1050	pg/mL
Dose-limiting Toxicities (DLT) and/or Maximum Plasma Level > 1000 pg/mL	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0		Events

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	10
Overall Study	STARTED	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	5
Overall Study	STARTED	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	13
Overall Study	Evaluable Subjects	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	7
Overall Study	Evaluable Subjects	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	3
Overall Study	Evaluable Subjects	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	6
Overall Study	COMPLETED	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	7
Overall Study	COMPLETED	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	5
Overall Study	COMPLETED	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	9
Overall Study	NOT COMPLETED	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bradycardia not requiring intervention	Cardiac disorders	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	1	7	1
other	Bradycardia not requiring intervention	Cardiac disorders	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	1	5	1
other	Bradycardia not requiring intervention	Cardiac disorders	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	1	9	1
other	Hypotension not requiring intervention	Cardiac disorders	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	7	0
other	Hypotension not requiring intervention	Cardiac disorders	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	1	5	1
other	Hypotension not requiring intervention	Cardiac disorders	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	9	0
other	New Intraventricular conduction delay	Cardiac disorders	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	7	0
other	New Intraventricular conduction delay	Cardiac disorders	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	0	5	0
other	New Intraventricular conduction delay	Cardiac disorders	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	9	0
other	Maximum Plasma Concentration	Cardiac disorders	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	7	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	7
Total, all-cause mortality	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	0	5
Total, all-cause mortality	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	9
Total, other adverse events	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	1	7
Total, other adverse events	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	2	5
Total, other adverse events	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	3	9
Total, serious adverse events	2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	7
Total, serious adverse events	2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	0	5
Total, serious adverse events	4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0	9

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03417999

GET https://conductscience.org/api/trials/v1/NCT03417999/registered

API reference For AI assistants