TRANSMUCOSAL ADMINISTRATION OF MIDAZOLAM FOR PREMEDICATION OF PEDIATRIC-PATIENTS - COMPARISON OF THE NASAL AND SUBLINGUAL ROUTES

Background: Nasal transmucosal midazolam is effective for premedicatio n of pediatric patients; however, 61-74% of these patients cry at nasa l drug administration. Sublingual benzodiazepines, including midazolam , are effective in adults. The current blinded randomized study compar ed acceptance of and behavioral responses to transmucosal midazolam ad ministered via the intranasal and sublingual routes. Methods: Ninety-t hree patients aged 0.5-10 yr were stratified by age: 30 infants and to ddlers, 0.5-2 yr; 39 preschoolers, 2.1-5 yr; and 24 school age, 5.1-10 yr. They were randomized to receive 0.2 mg/kg of midazolam in the nos e or under the tongue without or with additional flavoring. For the gr oup receiving sublingual flavored midazolam, the syringe tip was dippe d in candy flavor and sugar. Duration of crying and compliance with in structions for sublingual drug administration were recorded. Hemoglobi n oxygen saturation by pulse oximetry and sedation score were recorded by three observers before drug administration, at 2.5-min intervals f or 10 min, at separation from parents, and during induction with halot hane in O2. Results. Children accepted midazolam administered via the sublingual route better than that given intranasally. In children not crying before drug administration, the frequency and duration of cryin g was greater following intranasal compared with sublingual administra tion (71% vs. 18% (P < 0.0001) and 48 +/- 56 vs. 25 +/- 49 s (P = 0.00 4), respectively). Lack of total compliance with instructions for subl ingual administration did not alter drug effect, and there were no dif ferences between the three study groups in maximum sedation, response to separation from parents, and behavior at induction of anesthesia; 8 0% displayed adequate or excellent behavior. Finally, the addition of candy flavor did not improve acceptance of or compliance with sublingu al midazolam administration. Conclusions: Sublingual administration of midazolam is as effective as, and better accepted than, intranasal mi dazolam as a preanesthetic sedative in children.