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Our objective was to characterize baclofen pharmacokinetics and safety given orally and intravenously. Twelve healthy subjects were enrolled in a randomized, open-label, crossover study and received single doses of baclofen: 3 or 5 mg given intravenously and 5 or 10 mg taken orally with a 48-hour washout. Blood samples for baclofen analysis were collected pre-dose and at regular intervals up to 24 hours post-dose. Clinical response was assessed by sedation scores, ataxia, and nystagmus. Mean absolute bioavailability of oral baclofen was 74%. Dose-adjusted areas under the curve between the oral and intravenous arms were statistically different (P = .0024), whereas area under the curve variability was similar (coefficient of variation: 18%-24%). Adverse effects were mild in severity and not related to either dose or route of administration. Three- and 5-mg intravenous doses of baclofen were well tolerated. Seventy-four percent oral bioavailability indicates that smaller doses of intravenous baclofen are needed to attain comparable total drug exposures. [ABSTRACT FROM AUTHOR]

Objective: Assess safety and tolerance of intravenous (IV) baclofen using a dog model. Design: Prospective pharmacokinetic study involving 6 adult dogs. Two dogs received baclofen 10 mg oral and IV bolus doses. Subsequent 4 dogs were given IV boluses of 0.5, 1.0 and 1.5 mg/kg followed by constant infusion of baclofen (rates of 0.1, 0.2 and 0.4 mg/kg/hour). Also, dogs were given single IV 2 and 3 mg /kg bolus doses. Outcome measures included clinical observation scales and baclofen levels. Results: Oral bioavailability was 0.66 and 0.69 in 2 dogs. Following IV baclofen, terminal phase half-lives were 3.3 and 3.6 hours. Single bolus doses of 2 and 3 mg/kg caused mild to moderate clinical changes which were delayed at least 2 hours after peak blood levels. Boluses of 0.5 and 1.0 mg/kg with constant infusion between boluses were tolerated, however within 30 minutes of beginning constant infusion of 0.2 mg/kg/hr after the second bolus (1.0 mg/kg), dogs showed progressive sedation and ataxia. Clinical improvement occurred within 7 hours of stopping baclofen. Dogs appeared normal by the next morning. Conclusions: IV baclofen bolus doses of 0.5 to 3 mg/kg were well tolerated. Maximum clinical effect was delayed for at least 2 hours after peak plasma levels. [ABSTRACT FROM AUTHOR]

Objectives: The goals of this study were (1) to describe changes in functional status of pediatric patients with encephalitis from admission to discharge at an acute rehabilitation facility and (2) to identify the presence of persistent impairments on long term follow-up. Design: Retrospective chart review of 25 children admitted to one pediatric acute rehabilitation unit with a diagnosis of encephalitis from 2000-2013. Five patients were excluded due to a previous history of neurodevelopmental disabilities and two were excluded due to missing data. Data collected included demographic information, WeeFIM scores at admission and discharge, and impairments documented at the most recent follow-up visit. A 1 tailed paired t-test of WeeFIM scores and descriptive statistics for follow-up data were performed. Results: Average inpatient length of stay was 7.3 weeks. Statistically significant improvements were seen in WeeFIM scores in self-care, mobility, and cognition from admission to discharge (p <0.01 for each domain). Average follow-up length was 3 years. One child did not have follow-up data. On followup, 9/17 children had mobility impairments, 8/17 had cognitive impairments, and 11/17 had psychological impairments. All but one individual with mobility impairments were able to ambulate independently but had problems with movement disorders (n=6), hemiparesis (n=3), or slow gait (n=1). 7/8 patients with cognitive impairments required special education services. The most common psychological impairment was attention deficit (n=5). 9/11 patients who initially received enteral feedings were eating orally at follow-up. 11 patients continued to receive at least one type of outpatient therapy. Conclusions: This chart review showed that children with encephalitis improve during their inpatient rehabilitation stay, but that many are left with at least mild impairments on follow-up. It is important to ensure adequate follow-up services are in place to give these children the best opportunity for success. [ABSTRACT FROM AUTHOR]

Setting: Regional children's specialty hospital., Patient: 11 year old boy with a history of quadriparetic cerebral palsy (CP), shunted hydrocephalus, and continuous infusion of intrathecal baclofen (ITB) to treat hypertonicity., Case Description: The patient presented for a second opinion after experiencing three weeks of increased tone treated by shunt revision three times after two studies injecting contrast into the ITB pump catheter via the catheter access port did not demonstrate any extravasation of contrast material. Parents report that there was little change in his lower extremity tightness. His speech showed increased dysarthria during this time, and he had unusual difficulty with handling food. On evaluation, the patient had severely increased muscle tone. He also was noted to have palpable fluid in his pump pocket. Review of the X-rays that accompanied the patient revealed findings that caused us to be suspicious of a tear of the sleeve that is part of the mechanism that connects the intrathecal catheter to the pump. A 100 microgram bolus of ITB was administered, which did result in some relaxation.Assessment/Results: PATIENT underwent surgery at which time a torn pump-catheter connector was confirmed and replaced with a different type of connector. His symptoms resolved and he required a lower dose of ITB than on admission for significantly better tone control., Discussion: Individuals typically reach a stable dose of ITB and if they develop a need for increasing dose later, most frequently a catheter problem exists. Also, if there is fluid in the pump pocket, we have a high index of suspicion for this type of catheter/pump connector tear., Conclusion: In this case, careful evaluation of plain radiographs coupled with careful history taking, including the individual's response to interventions, was all that was necessary to make an accurate diagnosis.