Trial · NCT00652028
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
NCT00652028, Phase 2, Completed, Hospira, now a wholly owned subsidiary of Pfizer; results first posted 2015-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects. Trials, record NCT00652028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00652028
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
- NCT number
- NCT00652028
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Conditions
- Intubated and Mechanically Ventilated Pediatric Subjects
- Interventions
- Dexmedetomidine, midazolam; fentanyl
- First posted
- 2008-04-03
- Last updated
- 2017-04-13
- Results first posted
- 2015-08-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine |
| Primary | Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞) | ≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI. | Area under the concentration-time curve from time zero to the time infinity (AUC0-∞) for Dexmedetomidine |
| Primary | Observed Peak Plasma Concentration | ≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI. | Observed peak plasma concentration (Cmax) for Dexmedetomidine |
| Primary | Terminal Elimination Half-life (t1/2) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Terminal elimination half-life (t1/2) for Dexmedetomidine |
| Primary | Plasma Concentration at Steady State (Css) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Plasma concentration at steady state (Css) for Dexmedetomidine |
| Primary | Volume of Steady State Distribution (Vss) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Volume of steady state distribution (Vss) for Dexmedetomidine |
| Primary | Clearance (CL) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Clearance (CL) for Dexmedetomidine |
| Primary | Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score | Prior to loading (Baseline), 5 and 10 min during the load, at start of maintenance infusion and every 15 min for 1 hour, hourly during the maintenance period, before and within 5 min after midazolam or fentanyl dose during the dexmedetomidine infusion. | RSS Score range from 1 to 6: 1. Patient is anxious and agitated or restless, or both. 2. Patient is cooperative, orientated and tranquil. 3. Patient responds to command only. 4. Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus. 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6. Patient exhibits no response to stimulus. |
| Primary | Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl) | During the treatment period (Approximately 24 hours) | Number of subjects who received rescue medication for Sedation (Midazolam) and analgesics (Fentanyl) while intubated during Treatment Period |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for pharmacokinetic (PK) and pharmacodynamic (PD) analyses. | picograms*hr/mL | MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞) | ≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI. | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses. | picograms*hr/mL | MEAN |
| PRIMARY | Observed Peak Plasma Concentration | ≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI. | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses. | picograms per milliliter | MEAN |
| PRIMARY | Terminal Elimination Half-life (t1/2) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses. | hour | MEAN |
| PRIMARY | Plasma Concentration at Steady State (Css) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses. | picograms per milliliter | MEAN |
| PRIMARY | Volume of Steady State Distribution (Vss) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses. | Litre | MEAN |
| PRIMARY | Clearance (CL) | ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI. | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses. | Litre/hour | MEAN |
| PRIMARY | Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score | Prior to loading (Baseline), 5 and 10 min during the load, at start of maintenance infusion and every 15 min for 1 hour, hourly during the maintenance period, before and within 5 min after midazolam or fentanyl dose during the dexmedetomidine infusion. | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses. | units on a scale | MEAN |
| PRIMARY | Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl) | During the treatment period (Approximately 24 hours) | Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) | Dose Level 1 | 2681.332 | Standard Deviation 2353.3418 | picograms*hr/mL | |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) | Dose Level 2 | 6460.576 | Standard Deviation 3766.4657 | picograms*hr/mL | |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) | Dose Level 3 | 16992.540 | Standard Deviation 29927.3911 | picograms*hr/mL | |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) | Dose Level 4 | 28531.864 | Standard Deviation 17496.3985 | picograms*hr/mL | |
| Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞) | Dose Level 1 | 3153.518 | Standard Deviation 3343.3451 | picograms*hr/mL | |
| Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞) | Dose Level 2 | 6673.163 | Standard Deviation 3781.2183 | picograms*hr/mL | |
| Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞) | Dose Level 3 | 17300.539 | Standard Deviation 29935.7647 | picograms*hr/mL | |
| Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞) | Dose Level 4 | 28970.541 | Standard Deviation 17936.8970 | picograms*hr/mL | |
| Observed Peak Plasma Concentration | Dose Level 1 | 480.437 | Standard Deviation 625.9946 | picograms per milliliter | |
| Observed Peak Plasma Concentration | Dose Level 2 | 847.691 | Standard Deviation 633.7352 | picograms per milliliter |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 | 16 | |
| Overall Study | STARTED | Dose Level 2 | 14 | |
| Overall Study | STARTED | Dose Level 3 | 15 | |
| Overall Study | STARTED | Dose Level 4 | 14 | |
| Overall Study | COMPLETED | Dose Level 1 | 15 | |
| Overall Study | COMPLETED | Dose Level 2 | 13 | |
| Overall Study | COMPLETED | Dose Level 3 | 14 | |
| Overall Study | COMPLETED | Dose Level 4 | 14 | |
| Overall Study | NOT COMPLETED | Dose Level 1 | 1 | |
| Overall Study | NOT COMPLETED | Dose Level 2 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events212
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 | Atrial tachycardia | Cardiac disorders | Dose Level 1 | 0 | 16 | |
| other | Atrial tachycardia | Cardiac disorders | Dose Level 2 | 1 | 14 | |
| other | Atrial tachycardia | Cardiac disorders | Dose Level 3 | 0 | 15 | |
| other | Atrial tachycardia | Cardiac disorders | Dose Level 4 | 0 | 14 | |
| other | Bradycardia | Cardiac disorders | Dose Level 1 | 0 | 16 | |
| other | Bradycardia | Cardiac disorders | Dose Level 2 | 0 | 14 | |
| other | Bradycardia | Cardiac disorders | Dose Level 3 | 2 | 15 | |
| other | Bradycardia | Cardiac disorders | Dose Level 4 | 1 | 14 | |
| other | Nodal rhythm | Cardiac disorders | Dose Level 1 | 0 | 16 | |
| other | Nodal rhythm | Cardiac disorders | Dose Level 2 | 0 | 14 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | ||
| Total, all-cause mortality | Dose Level 2 | ||
| Total, all-cause mortality | Dose Level 3 | ||
| Total, all-cause mortality | Dose Level 4 | ||
| Total, other adverse events | Dose Level 1 | 11 | 16 |
| Total, other adverse events | Dose Level 2 | 12 | 14 |
| Total, other adverse events | Dose Level 3 | 10 | 15 |
| Total, other adverse events | Dose Level 4 | 13 | 14 |
| Total, serious adverse events | Dose Level 1 | 1 | 16 |
| Total, serious adverse events | Dose Level 2 | 0 | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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/NCT00652028
GET https://conductscience.org/api/trials/v1/NCT00652028/results?page=2