Back to resultsDexmedetomidine Premedication in Children
Primary Purpose
Premedication
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexmedetomidine
apple juice
Sponsored by
About this trial
This is an interventional prevention trial for Premedication focused on measuring Dexmedetomidine, child, premedication, emergence delirium, dental treatment
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria is age between 2 to 6 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.
Sites / Locations
- Sultan Keles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Dexmedetomidine
Control
Arm Description
Group administered 1µg/kg dexmedetomidine oral
Apple juice
Outcomes
Primary Outcome Measures
Ramsey Sedation Score
Sedation level
Secondary Outcome Measures
Parental Separation Anxiety Score
Separation anxiety
Full Information
NCT ID
NCT03174678
First Posted
May 28, 2017
Last Updated
June 1, 2017
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT03174678
Brief Title
Dexmedetomidine Premedication in Children
Official Title
The Effect of Oral Dexmedetomidine Premedication On Preoperative Cooperation and Emergence Delirium In Children Undergoing Dental Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
One Hundred children between the ages 2-6 years of ASA I status underwent full mouth dental rehabilitation were enrolled in the study. Group Dex (n=50) received 1µg/kg dexmedetomidine in apple juice and Group control (n=50) received apple juice only. Patients' Ramsey Sedation Scale (RSS), The Parental Seperation Anxiety Scale (PSAS), Mask Acceptance Scale (MAS) and Post anesthesia emergence delirium scale (PAEDS) and hemodynamic parameters were noted from their patient file. Premedication period was 45 minutes and measurements of RSS and hemodynamic parameters were recorded in baseline and every 15 minutes until the patients were transferred to the operating room. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and ANOVA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premedication
Keywords
Dexmedetomidine, child, premedication, emergence delirium, dental treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Retrospective study
Masking
Investigator
Masking Description
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Group administered 1µg/kg dexmedetomidine oral
Arm Title
Control
Arm Type
Other
Arm Description
Apple juice
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
1µg/kg dexmedetomidine oral
Intervention Type
Other
Intervention Name(s)
apple juice
Intervention Description
apple juice
Primary Outcome Measure Information:
Title
Ramsey Sedation Score
Description
Sedation level
Time Frame
45 minutes after premedication
Secondary Outcome Measure Information:
Title
Parental Separation Anxiety Score
Description
Separation anxiety
Time Frame
preoperative
Other Pre-specified Outcome Measures:
Title
Mask Acceptance Score
Description
Mask acceptance
Time Frame
Before induction
10. Eligibility
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria is age between 2 to 6 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sultan keles, Dr.
Organizational Affiliation
Pediatric dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Keles
City
Aydın
State/Province
Efeler
ZIP/Postal Code
09100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28298782
Citation
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.
Results Reference
background
PubMed Identifier
28904966
Citation
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.
Results Reference
derived
Learn more about this trial
Dexmedetomidine Premedication in Children
We'll reach out to this number within 24 hrs