Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

Primary outcomes

1. Facemask acceptance during drug delivery

   Time frame: 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)

2. Effect of sedation on children's future behavior

   Time frame: 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)

3. The 'ease of treatment completion' sing separate five-point scales.

   Time frame: 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.

4. Post-operative effects of the sedation

   Time frame: immediately after completion of the dental treatment procedures.

   This will be assessed according to Modified Vernon et al.

5. Analgo-sedative effect of each drug

   Time frame: 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

6. Analgo-sedative effect of each drug

   Time frame: during the sedation procedure (after drug administration until reaching satisfactory sedation)

   Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20

7. Analgo-sedative effect of each drug

   Time frame: during local anesthesia injection to start the operative procedure

   The analgesic effect of the sedative drugs will be assessed using "Face, Legs, Activity, Cry, Consolability" scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

8. Analgo-sedative effect of each drug

   Time frame: during the sedation procedure (from its onset till meeting discharge criteria)

   The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.

9. Analgo-sedative effect of each drug.

   Time frame: 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.

10. Amnesic effect of sedative agents.

    Time frame: immediately after completion of the dental treatment procedures.

    Anterograde amnesia: will be assessed according to a modification of Bulach et al.

11. Hemodynamic response of sedative agents.

    Time frame: during the sedation procedure (from its onset till meeting discharge criteria)

    Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer.

12. Hemodynamic response of sedative agents.

    Time frame: during the sedation procedure (from its onset till meeting discharge criteria)

    Vital sign: Heart rate will be counted

13. Hemodynamic response of sedative agents.

    Time frame: during the sedation procedure (from its onset till meeting discharge criteria)

    Vital sign: Oxygen saturation will be monitored using an oximeter