NCT03174678

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

March 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

May 28, 2017

Last Update Submit

June 1, 2017

Conditions

Keywords

Dexmedetomidinechildpremedicationemergence deliriumdental treatment

Outcome Measures

Primary Outcomes (1)

  • Ramsey Sedation Score

    Sedation level

    45 minutes after premedication

Secondary Outcomes (1)

  • Parental Separation Anxiety Score

    preoperative

Other Outcomes (1)

  • Mask Acceptance Score

    Before induction

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Group administered 1µg/kg dexmedetomidine oral

Drug: Dexmedetomidine

Control

OTHER

Apple juice

Other: apple juice

Interventions

1µg/kg dexmedetomidine oral

Also known as: Precedex
Dexmedetomidine

apple juice

Control

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Keles

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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
  • Keles S, Kocaturk O. The Effect of Oral Dexmedetomidine Premedication on Preoperative Cooperation and Emergence Delirium in Children Undergoing Dental Procedures. Biomed Res Int. 2017;2017:6742183. doi: 10.1155/2017/6742183. Epub 2017 Aug 20.

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • sultan keles, Dr.

    Pediatric dentistry

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 28, 2017

First Posted

June 2, 2017

Study Start

March 1, 2017

Primary Completion

May 1, 2017

Study Completion

May 25, 2017

Last Updated

June 2, 2017

Record last verified: 2017-05

Locations