Strabismus Clinical Trial
Verified date | July 2015 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Korea Food and Drug Administration (KFDA) |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 5 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 5-point agitation scale | 3. Scoring system for emergence agitation (behavior score) Sleeping Awake and calm Irritable and crying Inconsolable crying Severe restlessness and disorientation |
immediate postoperative period up to 1hour after surgery | No |
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