Pharmacokinetics, tolerability, and clinical effectiveness of quetiapine fumarate: an open-label trial in adolescents with psychotic disorders.

BACKGROUND: This is the first investigation of the pharmacokinetics, tolerability, and efficacy of quetiapine fumarate in adolescents with chronic or intermittent psychotic disorders. METHOD: Ten patients with DSM-IV chronic or intermittent psychotic disorders (ages 12.3 through 15.9 years) participated in an open-label, rising-dose trial and received oral doses of quetiapine twice daily (b.i.d.), starting at 25 mg b.i.d. and reaching 400 mg b.i.d. by day 20. The trial ended on day 23. Key assessments were pharmacokinetic analysis of plasma quetiapine concentrations and neurologic, safety, and efficacy evaluations. RESULTS: No statistically significant differences were observed between 100-mg b.i.d. and 400-mg b.i.d. quetiapine regimens for total body clearance, dose-normalized area under the plasma concentration-time curve, or dose-normalized premorning- or postmorning-dose trough plasma values obtained under steady-state conditions after multiple-dose regimens. No unexpected side effects occurred with quetiapine therapy, and no statistically significant changes from baseline were observed for the UKU Side Effect Rating Scale items that were rated. No serious adverse events or clinically important changes in hematology or clinical chemistry variables were reported. The most common adverse events were postural tachycardia and insomnia. Extrapyramidal side effects improved, as evidenced by significant (p < .05) decreases from baseline to endpoint in the mean Simpson-Angus Scale total scores and Barnes Akathisia Scale scores. Quetiapine improved positive and negative symptoms, as shown by significant (p < .05) decreases from baseline to endpoint in the mean Brief Psychiatric Rating Scale total score, the Clinical Global Impressions-Severity of Illness scale, and the Modified Scale for the Assessment of Negative Symptoms summary score. CONCLUSION: Quetiapine pharmacokinetics were dose proportional in adolescents and were similar to those previously reported for adults. Quetiapine was well tolerated and effective in the small number of adolescents studied.

Oral transmucosal fentanyl pretreatment for outpatient general anesthesia.

The oral transmucosal formulation of fentanyl citrate (OTFC) has been reported to be an effective sedative, providing convenient and atraumatic sedation for children prior to general anesthesia or painful diagnostic procedures. Thirty-three young children (24-60 months of age) scheduled for outpatient general anesthesia for treatment of dental caries were enrolled in this randomized placebo-controlled clinical trial. To determine the effectiveness of the OTFC premedication, patient behavior was evaluated using three distinct outcome ratings. A sedation score rated behavior in the waiting room prior to OTFC as well as 10 minutes and 20 minutes after OTFC. A separation score rated the child's response to being separated from his/her parent or guardian for transport to the dental operatory. Finally, a cooperation score rated the child's acceptance of the mask induction. The OTFC formulation was well tolerated by most of the children in this study. Compared with the placebo oralet, the active OTFC improved behavior for separation from the parent (P < .05) and cooperation with the mask induction (P < .05). The duration of surgery and the time of recovery did not differ between placebo and active premedication. Side effects including respiratory and cardiovascular complications were reported more frequently in the active fentanyl group. Continuous monitoring of respiratory function is essential when using this unique and effective formulation of fentanyl for pediatric preanesthetic sedation.

Transcatheter detachable balloon embolotherapy for catheter-induced pulmonary artery pseudoaneurysm.

Pulmonary artery pseudoaneurysm formation may be due to various etiologies, including trauma, pulmonary artery catheterization, infection, and tumor. Transcatheter embolization is a nonsurgical management technique that may be utilized in many of these patients to occlude the affected artery and to prevent further extravasation. Recently, two patients with pulmonary artery pseudoaneurysm formation after balloon-tipped catheter placement were successfully managed with transcatheter embolotherapy with detachable silicone balloons. The article describes their diagnosis and management.