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Oral Dexmedetomidine vs Midazoam For Premedication

A

Aydin Adnan Menderes University

Status and phase

Completed
Phase 4

Conditions

Premedication

Treatments

Drug: Midazolam
Drug: Precedex

Study type

Interventional

Funder types

Other

Identifiers

NCT03357718
2017/18

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

3 to 7 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • The inclusion criteria is age between 3 to 7 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Dexmedetomidine
Experimental group
Description:
2 µg/kg Precedex
Treatment:
Drug: Precedex
Midazolam
Active Comparator group
Description:
0.5 mg/kg dormicum
Treatment:
Drug: Midazolam

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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