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Dexmedetomidine Premedication in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174678
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
SULTAN KELES, Aydin Adnan Menderes University

Brief Summary:
The aim of this retrospective study was to detect the effectiveness of 1µg/kg oral dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the young children underwent complete dental treatment.

Condition or disease Intervention/treatment Phase
Premedication Drug: Dexmedetomidine Other: apple juice Phase 4

Detailed Description:
One Hundred children between the ages 2-6 years of ASA I status underwent full mouth dental rehabilitation were enrolled in the study. Group Dex (n=50) received 1µg/kg dexmedetomidine in apple juice and Group control (n=50) received apple juice only. Patients' Ramsey Sedation Scale (RSS), The Parental Seperation Anxiety Scale (PSAS), Mask Acceptance Scale (MAS) and Post anesthesia emergence delirium scale (PAEDS) and hemodynamic parameters were noted from their patient file. Premedication period was 45 minutes and measurements of RSS and hemodynamic parameters were recorded in baseline and every 15 minutes until the patients were transferred to the operating room. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and ANOVA.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Retrospective study
Masking: Single (Investigator)
Masking Description: Investigator
Primary Purpose: Prevention
Official Title: The Effect of Oral Dexmedetomidine Premedication On Preoperative Cooperation and Emergence Delirium In Children Undergoing Dental Treatment
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Dexmedetomidine
Group administered 1µg/kg dexmedetomidine oral
Drug: Dexmedetomidine
1µg/kg dexmedetomidine oral
Other Name: Precedex

Control
Apple juice
Other: apple juice
apple juice




Primary Outcome Measures :
  1. Ramsey Sedation Score [ Time Frame: 45 minutes after premedication ]
    Sedation level


Secondary Outcome Measures :
  1. Parental Separation Anxiety Score [ Time Frame: preoperative ]
    Separation anxiety


Other Outcome Measures:
  1. Mask Acceptance Score [ Time Frame: Before induction ]
    Mask acceptance



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The inclusion criteria is age between 2 to 6 years and American Society og Anesthesiology (ASA) grade 1.

Exclusion Criteria:

  • The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.

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): NCT03174678


Locations
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Turkey
Sultan Keles
Aydın, Efeler, Turkey, 09100
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
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Principal Investigator: sultan keles, Dr. Pediatric dentistry

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SULTAN KELES, Assist. Prof.Dr., Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03174678    
Other Study ID Numbers: 2017/1080
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by SULTAN KELES, Aydin Adnan Menderes University:
Dexmedetomidine
child
premedication
emergence delirium
dental treatment
Additional relevant MeSH terms:
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Emergence Delirium
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
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