The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery
1 other identifier
interventional
88
1 country
1
Brief Summary
Postoperative agitation in children is a well-documented clinical phenomenon with incidence ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the pediatric population and there is now increasing evidence to support the use of this drug as sedative and anesthetic adjunct in children. The purpose of this study is to determine whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 9, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJuly 16, 2015
July 1, 2015
6 months
January 9, 2012
July 15, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
objective pain score
1\. Objective pain score(OPS) Blood pressure 0\~2 points crying 0\~2points movement 0\~2points agitation 0\~2points posture 0\~2points complain of pain(where appropiraate by age) 0\~2points total 0\~10 points
immediate postoperative period up to 1hour after surgery
pediatric anesthesia emergence delirium (PAED) scale
2\. pediatric anesthesia emergence delirium (PAED) scale The Child makes eye contact with the caregiver 0\~4 The child's actions are purposeful. 0\~4 The child is aware of his'her surroundings. 0\~4 The child is restless. 0\~4 The child is insonsolable. 0\~4 total 0\~20 points
immediate postoperative period up to 1hour after surgery
5-point agitation scale
3\. Scoring system for emergence agitation (behavior score) 1. Sleeping 2. Awake and calm 3. Irritable and crying 4. Inconsolable crying 5. Severe restlessness and disorientation
immediate postoperative period up to 1hour after surgery
Study Arms (2)
dexmedetomidine
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery
Eligibility Criteria
You may qualify if:
- the patient undergoing the strabismus surgery in severance hospital
You may not qualify if:
- delayed development
- mental retardation
- cerebral palsy
- preoperative EKG abnormality e.g. cardiovascular conduction disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2012
First Posted
January 19, 2012
Study Start
September 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 16, 2015
Record last verified: 2015-07