Effectiveness of two sedative drugs on pediatric patients during dental treatment

INTERVENTION: Children between 3 and 6 years old referred to the pediatric dental clinics at Dental University Hospital, King Khaled Medical City, King Saud University for dental treatment under moderate sedation were included in the study after confirming that they satisfy the inclusion criteria and after obtaining consent from parents/legal guardians. Children were randomly selected to receive either intranasal fentanyl (1µg/kg) or saline as placebo in the first visit and the other in the second visit along with oral midazolam (0.7mg/kg). Then, video recording was done for all sedation visits to evaluate sedation and behavior status, onset of sedation, working time, and occurrence of any side effects. Then, a questionnaire regarding post discharge adverse effects of sedation and parents/legal guardians’ satisfaction and preference was delivered 24 hours after both sedation visits through a phone call with the parents/legal guardians. CONDITION: Sedation of pediatric patients during dental treatment ; Oral Health PRIMARY OUTCOME: ; 1. The sedation scores were recorded using the Modified Observer’s Alertness/ Sedation Scale (MOAA/S) after sedation at each visit; 2. The behavior scores were recorded using a four‐point scale (4 = combative, disoriented, or excited; 3 = moderately agitated; 2 = not calm; and 1 = calm) after sedation at each visit; 3. Post‐discharge adverse effects and parental satisfaction and preference were evaluated using a questionnaire 24 hours after each visit; SECONDARY OUTCOME: ; 1. The onset of sedation was measured as the minimum time interval required for child to become drowsy after administering the oral midazolam at each visit; 2. The time that elapses between the child becoming drowsy (sedation score = 4) and when the patient become alert and awake (sedation score = 5 or 6) was measured as the working time at each visit; INCLUSION CRITERIA: 1. 3 ‐ 6 years old 2. ASA I 3. Frankl behaviour rating scale 1 or 2 4. Mallampati score I or II 5. Brodsky tonsillar size scoring 0 or 1 or 2 6. Children within the normal range of weight 7. Children who needed two sedation visits for completion of dental treatment 8. Children who needed a comparable dental treatment (as regards restorations, pulp treatment, crowns, extraction) on both sides of the same jaw.