Neuromodulation : journal of the International Neuromodulation Society
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The aim of this study was to determine the efficacy and safety of intrathecal baclofen (ITB) delivered by a programmable pump for the chronic treatment of severe spasticity due to traumatic brain injury (TBI). Eight patients with severe spasticity following TBI, refractory to oral baclofen or who experienced intolerable side effects, were screened. The first five patients were enrolled in a research protocol that was approved by the Institutional Review Board for Human Research at Boston University Medical Center. ⋯ Reduction of spasticity resulted in improved levels of physical activity and locomotion and ease of care. Complications consisted of muscular hypotonia, areflexic bladder and urinary retention, erythema, and breakdown of the skin over the pump. Our results suggest that long-term intrathecal baclofen by an implanted programmable pump is a safe and effective method of treating severe intractable spasticity arising from traumatic brain injury.
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Internal infusion pumps are increasingly used as a safe method to deliver drugs in adult patients. However, a formal contraindication of this mode of therapy is the presence of a imbalance between the pump volume and the size of the abdominal wall as occurs in pediatric populations. We describe a method of implantation of an intrathecal infusion pump for baclofen therapy in a 10-year-old patient with cerebral palsy. ⋯ After three sessions, a pocket similar in size to an internal infusion pump was obtained. The result was a pump pocket with soft shaping and no edges that would not generate pressure sores or tissue tension after the pump insertion. This method could extend the use of internal infusion pumps in pediatric populations.
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This paper reviews data supporting the existence of individual, predictable, and unpredictable fluctuations in the severity of chronic pain and spasticity. It also evaluates what is known on the use of implantable programmable drug delivery systems for the management of predictable fluctuations in pain and spasticity. In addition to fixed rate infusion pumps, programmable drug delivery systems have been developed over the past 20 years for the management of predictable pain or spasticity fluctuations. ⋯ Ideally, the patient should be able to treat unpredictable fluctuations in symptoms, and a combination of patient controlled analgesia (PCA) with programmable drug delivery systems is currently in development. The future management of unpredictable fluctuations in the intensity of chronic pain and spasticity was subjected to critical evaluation. There seems to be a general agreement on the clinical importance of these phenomena, but stronger evidence is needed for a widespread change in the current management of most chronic pain patients.
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The calculation of the parameters of the pump is complicated for a mixture of two drugs in continuous intrathecal therapy with implantable and programmable pumps. It is important to determine the best proportion of drug solutions to obtain the desired clinical results and also to adapt their proportion to obtain the maximal volume of solution so that the time between two fillings is maximized. This paper proposes mathematical formulas that make easier and faster the calculation of the flow of the pump, the volume of each drug solution to be added to the pump, the concentration of each drug in the mixture, and the duration of the infusion. ⋯ The calculated values cannot be directly applied because the syringes used to measure the volume of each drug solution have limited accuracy. It is necessary to round the volume of each drug solution and to hold their sum equal to the total volume of the reservoir. All the parameters are then recalculated, and the physician has to choose between several combinations of volumes.