Effect of oral-transmucosal midazolam sedation on anxiety levels of 3-4 years old children during a Class II restorative procedure

AIM: A double-blind randomized control trial was conducted to assess the effect of oral-transmucosal midazolam sedation on changes in anxiety levels of precooperative children during a Class II amalgam restorative procedure. METHODOLOGY: A sample of 40 healthy, American Society of Anesthesiologists I, children aged 3-4 years having at least one carious primary mandibular molar requiring a Class II amalgam restoration with no previous dental history were randomly divided into experimental and control groups comprising of 20 children each. The children in the experimental group (Group I) received 0.5 mg/kg body weight of midazolam mixed in strawberry syrup and those in the control group (Group II) received the same syrup mixed in saline, 15 min prior to the restorative procedure. Routine nonpharmacological behavior management techniques were used in both groups. The anxiety levels were recorded using Venham's anxiety scale at the start and end of each procedural step. RESULTS: There was a significant (P < 0.001) reduction in the anxiety levels of children in the experimental group on entry into the operatory compared with the control group. Introduction of each fear evoking stimuli showed a somewhat similar increase in anxiety levels in the two groups. In spite of a similar trend, the anxiety levels remained much lower in Group I than in Group II. CONCLUSION: Midazolam in conjunction with behavior management is more helpful in relaxing the child initially than behavior management alone, thus increasing the chances of successful and easy accomplishment of further treatment steps.