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Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

NCT01901588 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2016-07-11

Study results available
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Summary

This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

Conditions

  • Strabismus
  • Delirium on Emergence
  • Pediatric Disorders

Interventions

DRUG

Dexmedetomidine

intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes

OTHER

Placebo

intraoperative dose of intravenous placebo

Sponsors & Collaborators

Principal Investigators

  • Jason Brown, MD · NYU School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-03-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01901588 on ClinicalTrials.gov