Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00652028
First received: April 1, 2008
Last updated: August 7, 2015
Last verified: August 2015
Results First Received: March 11, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: 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
No text entered.

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  
Number of Participants  
[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  
Gender  
[units: participants]
         
Female     10     8     9     5     32  
Male     6     6     6     9     27  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     1     0     0     0     1  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     1     2     1     2     6  
White     12     12     13     10     47  
More than one race     2     0     0     0     2  
Unknown or Not Reported     0     0     1     2     3  



  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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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


  Serious Adverse Events


  Other Adverse Events


  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, Inc.
ClinicalTrials.gov Identifier: NCT00652028     History of Changes
Other Study ID Numbers: DEX-08-01
Study First Received: April 1, 2008
Results First Received: March 11, 2015
Last Updated: August 7, 2015
Health Authority: United States: Food and Drug Administration
Guatemala: Ministry of Public Health and Social Assistance