Clinical trial NCT03827408: Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment
Official title: Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Anxiety
Keywords: Nebulized Dexmedetomidine
Nebulized Midazolam
Moderate sedation
Dental procedural sedation
Pediatric dentistry
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-02-01
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Detailed description: Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option.

Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.

Eligibility criteria: Inclusion Criteria:

* Age range 4-6 years
* Frankl scale score 2.
* ASA I or II physical status.
* Dental intervention under local anesthesia not requiring more than 30 minutes.
* No previous dental experience.
* Parent/guardian"s written consent.

Exclusion Criteria:

* Dental treatment indicated under general anesthesia.
* Presence of facial deformities.
* History of neurological or cognitive alterations.
* Mouth breathers.

Primary outcomes:
measure: Facemask acceptance during drug delivery
timeFrame: during the sedation procedure
measure: Effect of sedation on children's future behavior
timeFrame: after one week in the follow-up session
measure: The 'ease of treatment completion' sing separate five-point scales.
timeFrame: immediately after completion of the dental treatment procedures.
measure: Post-operative effects of the sedation
timeFrame: immediately after completion of the dental treatment procedures.
measure: Analgo-sedative effect of each drug
timeFrame: during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)
measure: Analgo-sedative effect of each drug
timeFrame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
measure: Analgo-sedative effect of each drug
timeFrame: during local anesthesia injection to start the operative procedure
measure: Analgo-sedative effect of each drug
timeFrame: during the sedation procedure (from its onset till meeting discharge criteria)
measure: Analgo-sedative effect of each drug.
timeFrame: during the sedation procedure (from its onset till meeting discharge criteria)
measure: Amnesic effect of sedative agents.
timeFrame: immediately after completion of the dental treatment procedures.
measure: Hemodynamic response of sedative agents.
timeFrame: during the sedation procedure (from its onset till meeting discharge criteria)
measure: Hemodynamic response of sedative agents.
timeFrame: during the sedation procedure (from its onset till meeting discharge criteria)
measure: Hemodynamic response of sedative agents.
timeFrame: during the sedation procedure (from its onset till meeting discharge criteria)
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Amira A El-Khatib, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Nadia A Wahba, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Karin ML Dowidar, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria Univerity
name: Tamer AM Ghoneim, PhD
role: STUDY_DIRECTOR
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