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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01512355

Enrollment

Registered

2012-01-19

Start date

2011-09-30

Completion date

2012-03-31

Last updated

2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strabismus

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.

Interventions

DRUGDexmedetomidine

After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery

DRUGplacebo group

normal saline\_02mcg/kg/hr

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026