Oral Dexmedetomidine vs Midazoam For Premedication

NCT ID: NCT03357718

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-06-01

Brief Summary

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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

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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.

Conditions

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Premedication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Retrospective clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Dexmedetomidine

2 µg/kg Precedex

Group Type EXPERIMENTAL

Precedex

Intervention Type DRUG

2 µg/kg oral

Midazolam

0.5 mg/kg dormicum

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

0.5 mg/kg

Interventions

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Precedex

2 µg/kg oral

Intervention Type DRUG

Midazolam

0.5 mg/kg

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine Dormicum

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Sultan KELES

Assist. Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sultan KELES, Dr.

Role: PRINCIPAL_INVESTIGATOR

Adnan Menderes University Faculty of Dentistry Aydın

References

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Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.

Reference Type BACKGROUND
PMID: 28298782 (View on PubMed)

Other Identifiers

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2017/18

Identifier Type: -

Identifier Source: org_study_id

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