Methods: In this crossover randomized clinical trial, 31 pediatric patients, 1-4 year(s) old were classified as definitely negative (Frankl 1969). Cases were randomly assigned for one of the two groups receiving either oral (ketamine 10 mg/kg, midazolam 0.2 mg/kg and atropine 0.02 mg/kg) or intramuscular (ketamine 6 mg/kg, midazolam 0.05 mg/kg and atropine 0.02 mg/kg) in the first visit followed by the other route in the second visit. Sedation score was recorded along with behavior rating (Houpt behavioral rating scale), physiological parameters, and side effects. Dental treatment was performed in all the cases when they were judged sedated by two independent pedodontists.
Results: Intramuscular route showed a significantly deeper level of sedation in patients when placed on dental chair (P=0.035) with less onset time (P<0.05). There were no significant differences in sleep, movement, cry and, overall behavior scores or even physiological parameters between the two treatment groups (P>0.05). Success rate at the first 15 minutes was 80.7% in the oral and 87.1% in the intramuscular routes. Despite an increase in blood pressure and heart rate, there were no cardiovascular or central nervous system difficulties. Only 9 cases presented small degree of desaturation due to laryngospasms (2 cases) and airway mal-alignments (7 cases). Practitioner and parents' satisfaction of the oral and intramuscular routes did not differ significantly (P>0.05).
Conclusions: Despite variable efficacy in some cases, oral ketamine, midazolam and atropine given orally provided sedation similar to that produced by the same drugs given intramuscularly.