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KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

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ClinicalTrials.gov Identifier: NCT03779282
Recruitment Status : Completed
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Khaled Dajani, Ochsner Health System

Brief Summary:
Strabismus surgery for children is a very common procedure, with a high incidence of emergence delerium in the recovery room. A combination of intravenous ketamine/dexmedetomidine, or ketodex, has been previously shown to reduce emergence delerium in children undergoing adenotonsillectomy. Here, we study its application in strabismus surgery.

Condition or disease Intervention/treatment
Emergence Delirium Strabismus Drug: Dexmedetomidine

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
control
pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex
study
pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex
Drug: Dexmedetomidine
see descriptions
Other Name: ketamine




Primary Outcome Measures :
  1. Pediatric Anesthesia Emergence Delirium scale scores [ Time Frame: up to 6 hours in recovery room ]
    A low total score would indicate less emergence delirium


Secondary Outcome Measures :
  1. wong-baker or numeric pain scores, depending on age [ Time Frame: up to 6 hours in recovery room ]
    A low total score would indicate less pain

  2. discharge time [ Time Frame: up to 24 hours ]
    time the patient is actually discharged from recovery room



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy children, aged 0-18 years, undergoing outpatient strabismus surgery under general anesthesia
Criteria

Inclusion Criteria:

  • ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria:

  • anything not meeting the above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779282


Locations
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United States, Louisiana
Ochsner Main Campus
Jefferson, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Investigators
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Principal Investigator: Khaled Dajani, MD Ochsner Health System

Publications:
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Responsible Party: Khaled Dajani, Assistant Professor, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03779282     History of Changes
Other Study ID Numbers: Pro00014439
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Strabismus
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action