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Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01528891
First Posted: February 8, 2012
Last Update Posted: January 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Peter J Davis MD, Children's Hospital of Pittsburgh
  Purpose
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.

Condition Intervention Phase
Tonsillectomy Drug: Dexmedetomidine Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children

Resource links provided by NLM:


Further study details as provided by Peter J Davis MD, Children's Hospital of Pittsburgh:

Primary Outcome Measures:
  • 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). ]
    beats per minute (bpm)

  • 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). ]

    mmHg

    Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.


  • 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). ]

    mmHg

    Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.



Secondary Outcome Measures:
  • 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.


Enrollment: 418
Study Start Date: January 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine
Dexmedetomidine
Drug: Dexmedetomidine
0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
Other Name: Precedex
Placebo Comparator: placebo
Normal saline
Other: Placebo

  Eligibility

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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
  • ASA 1,2,3
  • females who have started menses but have a negative urine pregnancy test

Exclusion Criteria:

  • patients with known dysrhythmias,
  • not recovering in the ICU
  • developmental delay,
  • autism communication disorder
  • bleeding disorder
  • PI discretion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528891


Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Peter J Davis, MD Children's Hospital of Pittsburgh of UPMC
  More Information

Responsible Party: Peter J Davis MD, Anesthesiologist-in-Chief, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT01528891     History of Changes
Other Study ID Numbers: PRO11070498
First Submitted: February 6, 2012
First Posted: February 8, 2012
Results First Submitted: September 16, 2015
Results First Posted: November 25, 2015
Last Update Posted: January 20, 2016
Last Verified: February 2012

Keywords provided by Peter J Davis MD, Children's Hospital of Pittsburgh:
tonsillectomy
emergence agitation

Additional relevant MeSH terms:
Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action