Dexmedetomidine Premedication in Children

Phase 4

Completed

• Conditions: Premedication
• Interventions: Drug: Dexmedetomidine; Other: apple juice

• Registration Number: NCT03174678
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-05
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-25
• Study First Submitted: 2017-05-28
• Study First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Study First Posted: 2017-06-02
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Group administered 1µg/kg dexmedetomidine oral
Control	apple juice	Apple juice

Primary Outcome Measures

Name	Time	Method
Ramsey Sedation Score	45 minutes after premedication	Sedation level

Secondary Outcome Measures

Name	Time	Method
Parental Separation Anxiety Score	preoperative	Separation anxiety

Trial Locations

Locations (1)

Sultan Keles; 🇹🇷 Aydın, Efeler, Turkey