Oral Dexmedetomidine vs Midazoam For Premedication

Premedication Clinical Trial

Official title:

Oral Dexmedetomidine vs Midazoam For Premedication And Emergence Delirium in Children Undergoing Dental Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357718
• Other study ID #: 2017/18
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2016
• Est. completion date: June 1, 2017

Study information

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

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 1, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premedication

Intervention

Drug:
• Precedex
2 µg/kg oral
• Midazolam
0.5 mg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

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
Primary	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	Parental Separation Anxiety Scale	Behavior of the child on seperation from the parents was assessed according to a four-point scale, i.e., the parental seperation anxiety scale (PSAS): 1= Easy seperation, 2=Whimpers but easily reassured, 3=Cries and cannot be easily reassured, but not clinging to parents, 4=Cries and clinging to parents. A PSAS score of 1 and 2 were considered as 'successful parental seperation'.	Preoperative
Secondary	Mask Acceptance Score	Mask acceptance was evaluated using a four-point scale, i.e., mask acceptance scale (MAS): 1=Excellent (unafraid, cooperative, and accepts mask easily), 2=Good (slight fear of mask , easily reassured), 3=Fair (moderate fear of mask, not calmed with reassurance), 4=Poor (terrified, crying, or combative). The score of 1 and 2 considered as 'satisfactory' mask acceptance.	Before induction