P Tyagi1, S Tyagi, A Jain. 1. Department of Pedodontics and Preventive Dentistry, People's Dental Academy, Bhopal, MP. drtyagip@gmail.com
Abstract
OBJECTIVE: To evaluate and compare the behavioral changes and effect of sedative techniques in pediatric dental patients using Oral Midazolam, Intravenous Midazolam and Oral Diazepam as sedative agents. METHOD: Triple blind randomized control trial with 40 patients aged between 2-10 years, exhibiting definitely negative behavior was considered. Patients were randomly assigned to one of the four treatment groups. Group I received midazolam 0.5 mg/kg orally, Group II received 0.5 mg/kg diazepam orally, Group III received 0.06 mg/kg midazolam intravenously and Group IV received oral placebo. Behavioral changes (sleep, crying, movement, and overall behavior) and effect of sedative techniques on pediatric patients were assessed. RESULTS: All the patients in group 3 were significantly better in post administrative behavior viz. sleep, crying and movement. Over all behavior scores for group 3 patients were significantly better than other three groups (p < 0.001). Positive behavior of patients in group 2 and 3 did not show significant difference but positive behavior in group 3 was significantly (p < 0.05) more than group 2. Placebo group showed the highest negative behavior CONCLUSION:Sedative effects of oral midazolam and oral diazepam were comparable, where as intravenous midazolam produced more sedation. Anxiolysis was found to be more in both the midazolam groups than the diazepam group. Most number of positive changes were observed in midazolam groups as compared to diazepam group.
RCT Entities:
OBJECTIVE: To evaluate and compare the behavioral changes and effect of sedative techniques in pediatric dental patients using Oral Midazolam, Intravenous Midazolam and Oral Diazepam as sedative agents. METHOD: Triple blind randomized control trial with 40 patients aged between 2-10 years, exhibiting definitely negative behavior was considered. Patients were randomly assigned to one of the four treatment groups. Group I received midazolam 0.5 mg/kg orally, Group II received 0.5 mg/kg diazepam orally, Group III received 0.06 mg/kg midazolam intravenously and Group IV received oral placebo. Behavioral changes (sleep, crying, movement, and overall behavior) and effect of sedative techniques on pediatric patients were assessed. RESULTS: All the patients in group 3 were significantly better in post administrative behavior viz. sleep, crying and movement. Over all behavior scores for group 3 patients were significantly better than other three groups (p < 0.001). Positive behavior of patients in group 2 and 3 did not show significant difference but positive behavior in group 3 was significantly (p < 0.05) more than group 2. Placebo group showed the highest negative behavior CONCLUSION: Sedative effects of oral midazolam and oral diazepam were comparable, where as intravenous midazolam produced more sedation. Anxiolysis was found to be more in both the midazolam groups than the diazepam group. Most number of positive changes were observed in midazolam groups as compared to diazepam group.