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

Not Applicable

Completed

• Conditions: Strabismus
• Interventions: Drug: placebo group; Drug: Dexmedetomidine

• Registration Number: NCT01512355
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-13
• Study First Posted: 2012-01-19
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo group	-
dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
objective pain score	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	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	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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of