Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Intubated and Mechanically Ventilated Pediatric Subjects
Intervention:	Drug: Dexmedetomidine, midazolam; fentanyl

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Dose Level 1	Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
Dose Level 2	Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
Dose Level 3	Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
Dose Level 4	Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours

Participant Flow:   Overall Study

	Dose Level 1	Dose Level 2	Dose Level 3	Dose Level 4
STARTED	16	14	15	14
COMPLETED	15	13	14	14
NOT COMPLETED	1	1	1	0
Adverse Event	1	0	0	0
No Longer Meets Entry Criteria	0	1	0	0
Physician Decision	0	0	1	0

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: Participants who received any amount of study drug were included in the Safety Population

Reporting Groups

	Description
Dose Level 1	Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
Dose Level 2	Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
Dose Level 3	Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
Dose Level 4	Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
Total	Total of all reporting groups

Baseline Measures

	Dose Level 1	Dose Level 2	Dose Level 3	Dose Level 4	Total
Overall Participants Analyzed; [Units: Participants]	16	14	15	14	59
Age; [Units: Years]; Mean (Standard Deviation)	6.358 (3.4673)	7.457 (4.5990)	8.379 (4.4962)	7.462 (4.2259)	7.395 (4.1571)
Age, Customized; [Units: Participants]
≥2 through <6 years	8	6	6	6	26
≥6 through <17 years	8	8	9	8	33
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	10 62.5%	8 57.1%	9 60.0%	5 35.7%	32 54.2%
Male	6 37.5%	6 42.9%	6 40.0%	9 64.3%	27 45.8%
Race (NIH/OMB); [Units: Participants]; Count of Participants
American Indian or Alaska Native	1 6.3%	0 0.0%	0 0.0%	0 0.0%	1 1.7%
Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Black or African American	1 6.3%	2 14.3%	1 6.7%	2 14.3%	6 10.2%
White	12 75.0%	12 85.7%	13 86.7%	10 71.4%	47 79.7%
More than one race	2 12.5%	0 0.0%	0 0.0%	0 0.0%	2 3.4%
Unknown or Not Reported	0 0.0%	0 0.0%	1 6.7%	2 14.3%	3 5.1%

  Outcome Measures

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1. Primary:

Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) [ Time Frame: ≤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. ]

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2. Primary:

Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞) [ Time Frame: ≤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. ]

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3. Primary:

Observed Peak Plasma Concentration [ Time Frame: ≤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. ]

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4. Primary:

Terminal Elimination Half-life (t1/2) [ Time Frame: ≤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. ]

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5. Primary:

Plasma Concentration at Steady State (Css) [ Time Frame: ≤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. ]

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6. Primary:

Volume of Steady State Distribution (Vss) [ Time Frame: ≤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. ]

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7. Primary:

Clearance (CL) [ Time Frame: ≤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. ]

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8. Primary:

Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score [ Time Frame: 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. ]

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9. Primary:

Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl) [ Time Frame: During the treatment period (Approximately 24 hours) ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Marcelo Garcia de Rocha MD, Global Medical Director
Organization: Hospira
phone: 224-212-4424
e-mail: marcelo.rocha@hospira.com

Responsible Party:	Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00652028 History of Changes
Other Study ID Numbers:	DEX-08-01
First Submitted:	April 1, 2008
First Posted:	April 3, 2008
Results First Submitted:	March 11, 2015
Results First Posted:	August 14, 2015
Last Update Posted:	April 13, 2017