Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
Peter J Davis MD, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01528891
First received: February 6, 2012
Last updated: December 15, 2015
Last verified: February 2012
Results First Received: September 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Tonsillectomy
Interventions: Drug: Dexmedetomidine
Other: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
418 patients overall were enrolled in the study. Of these patients, 18 failed screening prior to randomization into either treatment arm.

Reporting Groups
  Description
Dexmedetomidine

Dexmedetomidine

Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery

Placebo

Normal saline equivalent volume

Placebo


Participant Flow:   Overall Study
    Dexmedetomidine     Placebo  
STARTED     200     200  
COMPLETED     200     200  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Dexmedetomidine

Dexmedetomidine

Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery

Of the 200 patients in this treatment arm, 5 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol.

Placebo

Normal saline equivalent volume

Placebo

Of the 200 patients in this treatment arm, 2 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol.

Total Total of all reporting groups

Baseline Measures
    Dexmedetomidine     Placebo     Total  
Number of Participants  
[units: participants]
  195     198     393  
Age  
[units: participants]
     
<=18 years     195     198     393  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  6.1  (1.6)     5.8  (1.6)     6.0  (1.6)  
Gender  
[units: participants]
     
Female     96     97     193  
Male     99     101     200  
Region of Enrollment  
[units: participants]
     
United States     195     198     393  



  Outcome Measures
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1.  Primary:   Heart Rate (HR)   [ Time Frame: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). ]

2.  Primary:   Systolic Blood Pressure (SBP)   [ Time Frame: Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). ]

3.  Primary:   Diastolic Blood Pressure (DBP)   [ Time Frame: Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). ]

4.  Secondary:   Incidence of Emergence Agitation (EA)   [ Time Frame: The highest PAED score for each patient within the first 30 minutes after waking up was recorded. ]


  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: Peter J. Davis, MD
Organization: Children's Hospital of Pittsburgh of UPMC
phone: 4126925260
e-mail: davispj@anes.upmc.edu



Responsible Party: Peter J Davis MD, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT01528891     History of Changes
Other Study ID Numbers: PRO11070498
Study First Received: February 6, 2012
Results First Received: September 16, 2015
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration