Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01159262
First received: June 30, 2010
Last updated: July 23, 2015
Last verified: July 2015
Results First Received: January 24, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sedation
Interventions: Drug: Midazolam
Drug: Fentanyl/Morphine
Drug: Dexmedetomidine

  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
Dexmedetomidine 0.05 mcg/kg

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine 0.1 mcg/kg

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine 0.2 mcg/kg

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine


Participant Flow:   Overall Study
    Dexmedetomidine 0.05 mcg/kg     Dexmedetomidine 0.1 mcg/kg     Dexmedetomidine 0.2 mcg/kg  
STARTED     14     14     8  
COMPLETED     14     14     8  
NOT COMPLETED     0     0     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.
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Reporting Groups
  Description
Dexmedetomidine 0.05 mcg/kg

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine 0.1 mcg/kg

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine 0.2 mcg/kg

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Total Total of all reporting groups

Baseline Measures
    Dexmedetomidine 0.05 mcg/kg     Dexmedetomidine 0.1 mcg/kg     Dexmedetomidine 0.2 mcg/kg     Total  
Number of Participants  
[units: participants]
  14     14     8     36  
Age  
[units: participants]
       
<=18 years     14     14     8     36  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: weeks]
Mean (Standard Deviation)
  1.637  (1.8290)     1.098  (1.0849)     2.225  (1.5779)     1.558  (1.5382)  
Age, Customized  
[units: Participants]
       
= 28 weeks to < 36 weeks gestational age     6     6     0     12  
>= 36 weeks to <= 44 weeks gestational age     8     8     8     24  
Gender  
[units: participants]
       
Female     6     6     0     12  
Male     8     8     8     24  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     1     0     1  
White     10     10     6     26  
More than one race     1     0     0     1  
Unknown or Not Reported     3     3     2     8  
Region of Enrollment  
[units: participants]
       
United States     14     14     8     36  



  Outcome Measures
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1.  Primary:   Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion   [ Time Frame: During study drug administration (6 to 24 hours) ]

2.  Secondary:   Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion   [ Time Frame: During Study drug administration (6 to 24 hours) ]

3.  Secondary:   Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)   [ Time Frame: During Study drug administration (6 to 24 hours) ]

4.  Secondary:   Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)   [ Time Frame: During study drug administration (6 to 24 hours) ]

5.  Secondary:   Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)   [ Time Frame: During study drug administration (6 to 24 hours) ]

6.  Secondary:   Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)   [ Time Frame: During study drug administration (6 to 24 hours) ]

7.  Secondary:   Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)   [ Time Frame: During study drug administration (6 to 24 hours) ]

8.  Secondary:   Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)   [ Time Frame: During study drug administration (6 to 24 hours) ]

9.  Secondary:   Time to Successful Extubation in DEX-exposed Subjects   [ Time Frame: From start of DEX administration to extubation of each subject up to 7 days post-infusion ]


  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


No publications provided by Hospira, Inc.

Publications automatically indexed to this study:

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01159262     History of Changes
Other Study ID Numbers: DEX-09-08
Study First Received: June 30, 2010
Results First Received: January 24, 2014
Last Updated: July 23, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Guatemala: Ministry of Public Health and Social Assistance