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
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 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). ] [ Designated as safety issue: Yes ]
    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). ] [ Designated as safety issue: Yes ]

    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). ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Children's Hospital of Pittsburgh
Hospira, Inc.
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 
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

Keywords provided by Children's Hospital of Pittsburgh:
tonsillectomy
emergence agitation

Additional relevant MeSH terms:
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016