Dexmedetomidine Premedication in Children

Premedication Clinical Trial

Official title:

The Effect of Oral Dexmedetomidine Premedication On Preoperative Cooperation and Emergence Delirium In Children Undergoing Dental Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174678
• Other study ID #: 2017/1080
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2017
• Last updated: June 1, 2017
• Start date: March 1, 2017
• Est. completion date: May 25, 2017

Study information

• Verified date: May 2017
• Source: Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 25, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premedication

Intervention

Drug:
• Dexmedetomidine
1µg/kg dexmedetomidine oral

Other:
• apple juice
apple juice

Locations

Country	Name	City	State
Turkey	Sultan Keles	Aydin	Efeler

Sponsors (1)

Lead Sponsor	Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mask Acceptance Score	Mask acceptance	Before induction
Primary	Ramsey Sedation Score	Sedation level	45 minutes after premedication
Secondary	Parental Separation Anxiety Score	Separation anxiety	preoperative