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Completed

NCT Number: NCT03174678

Dexmedetomidine Premedication in Children

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.

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Key information

Conditions

Premedication Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–6 year

Study type

Interventional

Phase

Phase 4

Primary location

Sultan Keles

Aydin, Efeler, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

1µg/kg dexmedetomidine oral

Other names: Precedex

Apple juice

Other

apple juice

Primary outcomes

  1. Ramsey Sedation Score

    Time frame: 45 minutes after premedication

    Sedation level

Secondary outcomes

  1. Parental Separation Anxiety Score

    Time frame: preoperative

    Separation anxiety

Other outcomes

  1. Mask Acceptance Score

    Time frame: Before induction

    Mask acceptance

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Effect of Oral Dexmedetomidine Premedication On Preoperative Cooperation and Emergence Delirium In Children Undergoing Dental Treatment

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2017
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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