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Clinical Trials/NCT01512355
NCT01512355
Completed
Not Applicable

The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery

Yonsei University1 site in 1 country88 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Strabismus
Sponsor
Yonsei University
Enrollment
88
Locations
1
Primary Endpoint
objective pain score
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
March 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • the patient undergoing the strabismus surgery in severance hospital

Exclusion Criteria

  • delayed development
  • mental retardation
  • cerebral palsy
  • preoperative EKG abnormality e.g. cardiovascular conduction disorder

Arms & Interventions

dexmedetomidine

Intervention: Dexmedetomidine

placebo

Intervention: placebo group

Outcomes

Primary Outcomes

objective pain score

Time Frame: immediate postoperative period up to 1hour after surgery

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

pediatric anesthesia emergence delirium (PAED) scale

Time Frame: immediate postoperative period up to 1hour after surgery

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

5-point agitation scale

Time Frame: immediate postoperative period up to 1hour after surgery

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

Study Sites (1)

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