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Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy (DexT&A)
This study has been completed.
Study NCT00654511   Information provided by Children's Research Institute

First Received on April 3, 2008.   Last Updated on March 28, 2011   History of Changes
Results First Received: February 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tonsillitis
Interventions: Drug: Fentanyl
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
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Reporting Groups
  Description
Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation

Participant Flow:   Overall Study
    Fentanyl 1 Microgram/Kilogram Intravenous (IV)     Fentanyl 2 Micrograms/Kilogram Intravenous (IV)     Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)     Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)  
STARTED     26     25     25     25  
COMPLETED     26     25     25     25  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation

Baseline Measures
    Fentanyl 1 Microgram/Kilogram Intravenous (IV)     Fentanyl 2 Micrograms/Kilogram Intravenous (IV)     Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)     Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)     Total  
Number of Participants  
[units: participants]
 		  26     25     25     25     101  
Age  
[units: participants]
 		         
<=18 years     26     25     25     25     101  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  4.17  ± 2.33     4.83  ± 2.45     5.17  ± 2.33     4.92  ± 2.27     4.77  ± 2.34  
Gender  
[units: participants]
 		         
Female     9     11     12     11     43  
Male     17     14     13     14     58  
Region of Enrollment  
[units: participants]
 		         
United States     26     25     25     25     101  



  Outcome Measures
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1.  Primary:   Time to First Morphine Dose   [ Time Frame: up to 24 hours ]
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2.  Primary:   Morphine Rescue   [ Time Frame: up to 24 hours ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
Organization: Children's National Medical Center
phone: 202-476-4867 ext 4867
e-mail: jfinkel@cnmc.org


No publications provided by Children's Research Institute

Publications automatically indexed to this study:
Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. Epub 2011 Apr 2.


Responsible Party: Julia C. Finkel, MD, Children's National Medical Center
ClinicalTrials.gov Identifier: NCT00654511     History of Changes
Other Study ID Numbers: 3502, Agreement #10698
Study First Received: April 3, 2008
Results First Received: February 23, 2011
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board





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