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Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects

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ClinicalTrials.gov Identifier: NCT00875550
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : October 30, 2014
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sedation
Interventions: Drug: Dexmedetomidine
Drug: Midazolam
Drug: Fentanyl
Drug: Morphine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 Low Dose

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Dexmedetomidine High Dose

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.


Participant Flow:   Overall Study
    Dexmedetomidine Low Dose   Dexmedetomidine High Dose
STARTED   89   86 
COMPLETED   77   76 
NOT COMPLETED   12   10 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Dexmedetomidine Low Dose

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Dexmedetomidine High Dose

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Total Total of all reporting groups

Baseline Measures
   Dexmedetomidine Low Dose   Dexmedetomidine High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 89   86   175 
Age 
[Units: Years]
Mean (Standard Deviation)
 2.35  (3.437)   2.85  (4.172)   2.60  (3.814) 
Age 
[Units: Participants]
     
<=18 years   89   86   175 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age, Customized 
[Units: Participants]
     
>= 1 month to < 24 months   63   60   123 
>=24 months to < 17 years old   26   26   52 
Gender 
[Units: Participants]
     
Female   36   38   74 
Male   53   48   101 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   3   3   6 
Asian   0   2   2 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   14   14   28 
White   64   62   126 
More than one race   1   1   2 
Unknown or Not Reported   7   3   10 
American Society of Anaesthesiologists (ASA) classification 
[Units: Participants]
     
P1 - Normal healthy patient (PT)   3   5   8 
P2 - PT w/ mild systemic disease   28   16   44 
P3 - PT w/ severe systemic disease)   50   53   103 
P4 - PT w/ constant threat to life)   8   12   20 
P5 - Moribund patient   0   0   0 
P6 - A declared brain-dead patient   0   0   0 


  Outcome Measures

1.  Primary:   Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.   [ Time Frame: 6 to 24 hours ]

2.  Secondary:   Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated   [ Time Frame: 6 to 24 hours ]

3.  Secondary:   Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated   [ Time Frame: 6 to 24 hours ]

4.  Secondary:   Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated   [ Time Frame: 6 to 24 hours ]

5.  Secondary:   Time to First Dose of Rescue Medication for Sedation and Analgesia   [ Time Frame: 6 to 24 hours ]

6.  Secondary:   Time to Successful Extubation   [ Time Frame: 6 to 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT00875550     History of Changes
Other Study ID Numbers: DEX-08-05
First Submitted: March 31, 2009
First Posted: April 3, 2009
Results First Submitted: May 30, 2014
Results First Posted: October 30, 2014
Last Update Posted: August 14, 2015