Objective and subjective measures of the pharmacodynamic effects of Adderall in the treatment of children with ADHD in a controlled laboratory classroom setting.

In a randomized double-blind crossover study of children with attention deficit hyperactivity disorder (ADHD), the time course effects of four doses of Adderall (5, 10, 15, and 20 mg) and an inactive (placebo) control, and an active (Ritalin) control were evaluated. A laboratory classroom setting was established in which subjective (teacher ratings of deportment and attention) and objective (scores on math tests) measurements were taken every 1.5 hours across the day. In addition to significant time and dose effects of Adderall, significant time-of-day effects were documented in the placebo condition for the subjective measure of deportment and objective measures of performance. Regression analyses were used to estimate the magnitude of these baseline effects. Correlations across time were used to evaluate the test-retest reliability of each measure in the face of these time-dependent placebo effects. After placebo/time adjustments, within-subject correlations between pairs of measures were used to evaluate the validity of the math test as a measure of response to stimulant medication.

Clinical application of ketamine ointment in the treatment of sympathetically maintained pain.

The objective of this study was to determine the clinical efficacy of topical ketamine in relieving sympathectically maintained pain, including complex regional pain syndrome types I and II, involving the upper and/or lower extremities. In an open clinical pilot study of five referral patients diagnosed with sympathetically maintained pain who were unresponsive to conventional modalities, a single dose of topical ketamine was administered. Age, gender, duration or degree of disease and concurrent medication were not controlled. Ketamine was prepared for transdermal delivery in pluronic lethicin organogel (PLO) in calibrated applicators. Concentrations ranged from 10 to `50 mg/mL. Dosage ranged from 10 mg to 700 mg per single application. Each dosage was deternined clinically based on location and suface area of involvement. Pain intensity was measured using a validated mumeric analogue scale (NAS). Ketamine in PLO applied to the uper and/or lower extremities with sympathetically maintained pain resulted in significant pain reduction relative to pretreatment NAS of 65% to 100% . Initial response was within 20 seconds to three minutes, with NAS rating 15 minutes postapplication. No reported side effect occurred on patient follow-up at 24 and 48 hours. Single-dose, topical application of ketamine in PLO (patent pending) appears clinically effective in relieving sympathetically maintained pain of the extremities without apparent side effects. Further controlled studies are warranted to define patient selection, optimize dosage and validate the prominent analgesic effects obtained in this heretofore difficult-to-treat pain syndrome. This was an independent study in joint cooperation with representatives from the Univesity of California at Irvine, Loma Linda University Medical Center and private practice.