Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
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ClinicalTrials.gov Identifier: NCT01528891 |
Recruitment Status
:
Completed
First Posted
: February 8, 2012
Results First Posted
: November 25, 2015
Last Update Posted
: March 8, 2018
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Sponsor:
Peter Davis
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Peter Davis, University of Pittsburgh
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Tracking Information | ||||
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First Submitted Date ICMJE | February 6, 2012 | |||
First Posted Date ICMJE | February 8, 2012 | |||
Results First Submitted Date | September 16, 2015 | |||
Results First Posted Date | November 25, 2015 | |||
Last Update Posted Date | March 8, 2018 | |||
Study Start Date ICMJE | January 2012 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Cardiovascular Measurements [ Time Frame: 5 Minutes after injection ] Vital Signs will be measured and recorded every minute for the first 5 minutes after injection
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Change History | Complete list of historical versions of study NCT01528891 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Incidence of Emergence Agitation (EA) [ Time Frame: The highest PAED score for each patient within the first 30 minutes after waking up was recorded. ] Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of >10 and >12 were considered to be agitated.
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Original Secondary Outcome Measures ICMJE |
Incidence of Emergence Agitation [ Time Frame: First 30 minutes in recovery room ] USING A PAED SCORE EMERGENCE AGITATION WILL SCORES WILL BE RECORDED
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation | |||
Official Title ICMJE | Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children | |||
Brief Summary | To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Tonsillectomy | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
418 | |||
Original Estimated Enrollment ICMJE |
400 | |||
Actual Study Completion Date | August 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 4 Years to 10 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01528891 | |||
Other Study ID Numbers ICMJE | PRO11070498 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Peter Davis, University of Pittsburgh | |||
Study Sponsor ICMJE | Peter Davis | |||
Collaborators ICMJE | Hospira, now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Pittsburgh | |||
Verification Date | March 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |