NCT03357718

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
Last Updated

May 29, 2020

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

November 24, 2017

Last Update Submit

May 28, 2020

Conditions

Premedication

Keywords

premedication

Outcome Measures

Primary Outcomes (1)

  • Ramsey Sedation Scale

    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.

    45 minutes after premedication

Secondary Outcomes (2)

  • Parental Separation Anxiety Scale

    Preoperative

  • Mask Acceptance Score

    Before induction

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

2 µg/kg Precedex

Drug: Precedex

Midazolam

ACTIVE COMPARATOR

0.5 mg/kg dormicum

Drug: Midazolam

Interventions

PrecedexDRUG

2 µg/kg oral

Also known as: Dexmedetomidine
Dexmedetomidine
MidazolamDRUG

0.5 mg/kg

Also known as: Dormicum
Midazolam

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28298782BACKGROUND

MeSH Terms

Interventions

DexmedetomidineMidazolam

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sultan KELES, Dr.

    Adnan Menderes University Faculty of Dentistry Aydın

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Retrospective clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.Dr.

Study Record Dates

First Submitted

November 24, 2017

First Posted

November 30, 2017

Study Start

November 1, 2016

Primary Completion

May 30, 2017

Study Completion

June 1, 2017

Last Updated

May 29, 2020

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Results