Oral Dexmedetomidine vs Midazoam For Premedication

Phase 4

Completed

• Conditions: Premedication
• Interventions: Drug: Precedex; Drug: Midazolam

• Registration Number: NCT03357718
• Lead Sponsor: Aydin Adnan Menderes University

Brief Summary

The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures.

Detailed Description

The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the control group (n=26) received 0.5 mg/kg midazolam in apple juice.

The patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale, mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test, student t test, and analysis of variance in SPSS.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2017-05-30
• Study Completion: 2017-06-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-24
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-11-30
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• The inclusion criteria is age between 3 to 7 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	Precedex	2 µg/kg Precedex
Midazolam	Midazolam	0.5 mg/kg dormicum

Primary Outcome Measures

Name	Time	Method
Ramsey Sedation Scale	45 minutes after premedication	Sedation level is evaluated due to patient behavior. 1= Patient is anxious and agitated or restless or both, 2=Patient is cooperative, oriented, and tranquil, 3=Patient responds to command only, 4=Patient exhibits brisk response to light glabellar tap, 5=Patient exhibits sluggish response to light glabellar tap, 6=Patient exhibits no response.A Ramsay sedation score '1' was considered as unsatisfactory and "≥ 2" was considered as satisfactory sedation.

Secondary Outcome Measures

Name	Time	Method
Parental Separation Anxiety Scale	Preoperative	Behavior of the child on seperation from the parents was assessed according to a four-point scale, i.e., the parental seperation anxiety scale (PSAS): 1= Easy seperation, 2=Whimpers but easily reassured, 3=Cries and cannot be easily reassured, but not clinging to parents, 4=Cries and clinging to parents. A PSAS score of 1 and 2 were considered as 'successful parental seperation'.
Mask Acceptance Score	Before induction	Mask acceptance was evaluated using a four-point scale, i.e., mask acceptance scale (MAS): 1=Excellent (unafraid, cooperative, and accepts mask easily), 2=Good (slight fear of mask , easily reassured), 3=Fair (moderate fear of mask, not calmed with reassurance), 4=Poor (terrified, crying, or combative). The score of 1 and 2 considered as 'satisfactory' mask acceptance.