Oral Dexmedetomidine vs Midazoam For Premedication

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

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.

Study Overview

• Status: Completed
• Conditions: Premedication
• Intervention / Treatment: Drug: Precedex; Drug: Midazolam

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; 2 µg/kg Precedex	Drug: Precedex; 2 µg/kg oral; Other Names: Dexmedetomidine
Active Comparator: Midazolam; 0.5 mg/kg dormicum	Drug: Midazolam; 0.5 mg/kg; Other Names: Dormicum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Sultan KELES, Dr., Adnan Menderes University Faculty of Dentistry Aydın

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: premedication
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 2017/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No