Dental Anxiety
Conditions
Keywords
Nebulized Dexmedetomidine, Nebulized Midazolam, Moderate sedation, Dental procedural sedation, Pediatric dentistry
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.
Interventions
DRUGMidazolam group (MDZ)
IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
DRUGDexmedetomidine group (DEX)
IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
DRUGCombination of Midazolam and Dexmedetomidine (MDZ/DEX)
Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(
Sponsors
Alexandria University
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The researcher, statistician and participants will be blinded to the intervention group. Only the supervisor and the anesthesiologist will be aware of the allocation group. After data collection is completed, the randomization code will be broken to reveal the allocation group.
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
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/guardians written consent.
Exclusion criteria
* Dental treatment indicated under general anesthesia. * Presence of facial deformities. * History of neurological or cognitive alterations. * Mouth breathers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facemask acceptance during drug delivery | during the sedation procedure | It will be evaluated according to Zanaty & Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily) |
| Effect of sedation on children's future behavior | after one week in the follow-up session | Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4) |
| The 'ease of treatment completion' sing separate five-point scales. | immediately after completion of the dental treatment procedures. | This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered. |
| Post-operative effects of the sedation | immediately after completion of the dental treatment procedures. | This will be assessed according to Modified Vernon et al. |
| Analgo-sedative effect of each drug | during the sedation procedure (time taken from drug administration till reaching satisfactory sedation) | Onset of Sedation from drug administration until the onset of satisfactory sedation |
| Analgo-sedative effect of each drug. | during the sedation procedure (from its onset till meeting discharge criteria) | Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded. |
| Amnesic effect of sedative agents. | immediately after completion of the dental treatment procedures. | Anterograde amnesia: will be assessed according to a modification of Bulach et al. |
| Hemodynamic response of sedative agents. | during the sedation procedure (from its onset till meeting discharge criteria) | Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer. |
Countries
Egypt
Outcome results
None listed