Oral Dexmedetomidine vs Midazoam For Premedication And Emergence Delirium in Children Undergoing Dental Treatment
Overview
- Phase
- Phase 4
- Intervention
- Precedex
- Conditions
- Premedication
- Sponsor
- Aydin Adnan Menderes University
- Enrollment
- 52
- Primary Endpoint
- Ramsey Sedation Scale
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Detailed 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.
Investigators
Sultan KELES
Assist. Prof.Dr.
Aydin Adnan Menderes University
Eligibility Criteria
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.
Arms & Interventions
Dexmedetomidine
2 µg/kg Precedex
Intervention: Precedex
Midazolam
0.5 mg/kg dormicum
Intervention: Midazolam
Outcomes
Primary Outcomes
Ramsey Sedation Scale
Time Frame: 45 minutes after premedication
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.
Secondary Outcomes
- Parental Separation Anxiety Scale(Preoperative)
- Mask Acceptance Score(Before induction)