RESUMEN
BACKGROUND: Tissue expansion is a well-established technique for soft tissue reconstruction in the pediatric population. We present a case series of this technique to create a safe pocket for baclofen pump insertion to minimize risk of complications including pump migration, extrusion, wound dehiscence and infection. METHODS: A case series of 3 pediatric patients undergoing tissue expansion prior to baclofen pump insertion at a single center in Melbourne. The expansion procedure was performed by senior surgeon N Low in all cases, and patients followed up 6 months after expander-pump exchange. The study was conducted over a 4-year period 2019 to 2023. RESULTS: We suffered 2 minor complications with the tissue expansion process including cellulitis and pump deflation. Neither complication precluded further tissue expansion nor led to premature removal of the expander. All patients proceeded to safely complete expander-pump exchange. One patient suffered a small (6 mL) abdominal seroma associated with pump insertion, which required no intervention. All patients have had a successful outcome 6 months after pump insertion. CONCLUSIONS: We describe a reliable and reproducible approach in creating a safe abdominal wall pocket to better accommodate baclofen pump insertion. Our series has overcome the imbalance between device size and abdominal wall pocket, now offering an alternative approach to achieve the safe delivery of intrathecal baclofen in the pediatric population.
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Baclofeno , Bombas de Infusión Implantables , Relajantes Musculares Centrales , Expansión de Tejido , Humanos , Baclofeno/administración & dosificación , Expansión de Tejido/métodos , Expansión de Tejido/instrumentación , Niño , Femenino , Masculino , Relajantes Musculares Centrales/administración & dosificación , Adolescente , Parálisis Cerebral/complicaciones , Dispositivos de Expansión Tisular , PreescolarRESUMEN
OBJECTIVE: To analyze the effectiveness and tolerability of various regimens for the use of tolperisone hydrochloride (TH) in the treatment of patients with acute nonspecific lower back pain (ALBP). MATERIAL AND METHODS: 90 patients with ALBP (54.3 [48.7; 61.3] years) were divided into 2 groups: group 1 (n=45) received basic therapy - NSAIDs, B vitamins and TH sustained release (450 mg/day per os), group 2 (n=45) used basic treatment and TH 2 ml intramuscularly 2 times a day for 5 days with a transition to a TH sustained release 450 mg/day per os. The total duration of the study was 30 days. We analyzed the visual analogue pain scale (VAS-B), the results of the modified modified Schober test (MMST), the medication adherence scale (Drug Attitude Inventory - DAI-10), the Epworth daytime sleepiness scale (ESS), functional activity associated with low back pain (Roland-Maurice questionnaire, RM), duration of TH intake (days), frequency and characteristics of adverse events (AE). At the screening visit, all patients were additionally divided depending on the intensity of pain according to VAS-B («mild¼, «moderate¼, «severe¼). RESULTS: There were no significant differences on the VAS-B scale between groups 1 and 2 in patients with mild pain; there was significantly more complete pain control in group 2 with moderate pain after 14 and 30 days, (p=0.0013, 14 days; p=0.0021, 30 days); among patients with severe pain, the best result after 30 days was observed in group 2 (p=0.0016). In all patients the range of motion in the lumbosacral spine (MSST) significantly increased and functional activity (RM) improved compared to the initial state: more significant in group 2 with moderate pain after 14 and 30 days and with severe pain after 30 days. There was a high adherence to therapy (DAI-10), more pronounced in the first 14 days in patients of group 1. Excessive daytime sleepiness (ESS) was not observed. For moderate pain, patients in group 2 used TH for a significantly shorter period of time (16.4±1.6 days) compared to patients in group 1 (19.6±2.2 days, p=0.0022). AE were mild and did not serve as a reason to refuse therapy. CONCLUSION: A protocol for prescribing TH was proposed, based on stratification of patients according to VAS-B.The use of TH for ALBP is effective and safe. The proposed protocol for stratifying patients according to VAS-B level allows identifying the patients with step-by-step scheme of prescribing the drug for a period of 14 to 30 days.
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Dolor de la Región Lumbar , Dimensión del Dolor , Tolperisona , Humanos , Dolor de la Región Lumbar/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Femenino , Tolperisona/uso terapéutico , Tolperisona/administración & dosificación , Tolperisona/efectos adversos , Resultado del Tratamiento , Inyecciones Intramusculares , Antiinflamatorios no Esteroideos/uso terapéutico , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/efectos adversos , Relajantes Musculares Centrales/uso terapéutico , Relajantes Musculares Centrales/administración & dosificación , Relajantes Musculares Centrales/efectos adversosRESUMEN
INTRODUCTION: Patients managed in the Pediatric Palliative Care Integral Unit (PPCIU) have serious neurological conditions that involve significant damage at central nervous system level. The movement disorder is a very common clinical problem and for the patients where an adequate control of muscle tone is not achieved with usual techniques or drugs, intrathecal baclofen therapy (IBT) should be considered. MATERIALS AND METHODS: Descriptive retrospective study based on the review of clinical records of patients who received IBT being followed by the PPCIU of Madrid Autonomous Region in the timeframe between September 2012 and February 2021. RESULTS: IBT was implanted in 8 patients affected by infantile cerebral palsy (ICP) with a Gross Motor Function Scale (GMFCS) IV-V, 3 patients was a Pantothenate kinase deficit-associated neurodegeneration (PKAN), 2 had Acquired Brain Damage, and the remaining 3 had, respectively, 2 glutaric aciduria type I (GA-1), and poly-malformative syndrome. In all patients we observed a period of clinical stability after IBT, we call this period "honeymoon". Two patients died while in the honeymoon period, at 24.9 and 19.6 months from implantation of the pump; the median of duration of the honeymoon period in the remaining 14 was 14.4 months (IQ: 8.3-25.8). CONCLUSIONS: IBT was not only used in patients with non-progressive diseases, but also in the group of patients with neurodegenerative or progressive diseases. In all of them, after implantation of the device, we have objectified a period of clinical stability and a better control of muscle tone disorders.
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Baclofeno , Distonía , Inyecciones Espinales , Relajantes Musculares Centrales , Espasticidad Muscular , Cuidados Paliativos , Humanos , Baclofeno/administración & dosificación , Baclofeno/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Estudios Retrospectivos , Relajantes Musculares Centrales/uso terapéutico , Relajantes Musculares Centrales/administración & dosificación , Distonía/tratamiento farmacológico , Masculino , Femenino , Preescolar , Niño , Parálisis Cerebral/tratamiento farmacológico , Lactante , Adolescente , Neurodegeneración Asociada a Pantotenato Quinasa/tratamiento farmacológicoRESUMEN
OBJECTIVE: Intraventricular baclofen has been reported as an alternative to intrathecal baclofen for managing refractory spasticity and dystonia in some circumstances. In this report, we described a frame-based stereotactic approach for precisely positioning of the infusion catheter into the third ventricle. MATERIAL AND METHODS: High resolution contrast-enhanced anatomical MR sequences was acquired prior to surgery for pre-planning. Catheter trajectory was planned to pass from the lateral ventricle to the third ventricle through the Foramen of Monro. The surgical procedure was adapted from the frame-based deep brain stimulation surgery. The Touch-Loc kit (SceneRay, China) was used to temporarily secure the catheter in place during the surgery. From July 2022 to December 2022, three patients suffering from intractable spasticity and/or secondary dystonia received IVB successfully using the described technique. RESULTS: No severe adverse events, including death, intracranial hemorrhage, infection, catheter migration or fracture, were documented at the last follow-up (range: 12â24 months). Transient side effects included mild nausea following the initiation of infusion or the increase in infusion rate. All three patients responded to the IVB. CONCLUSIONS: The described frame-based stereotactic technique for IVB catheter implant is feasible and could be quickly mastered by neurosurgeons in related fields. Larger prospective cohorts with longer follow-up periods are necessary to further evaluate the long-term safety and efficacy of this procedure.
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Baclofeno , Distonía , Relajantes Musculares Centrales , Espasticidad Muscular , Humanos , Baclofeno/administración & dosificación , Baclofeno/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/cirugía , Espasticidad Muscular/etiología , Masculino , Relajantes Musculares Centrales/administración & dosificación , Relajantes Musculares Centrales/uso terapéutico , Femenino , Adulto , Persona de Mediana Edad , Distonía/tratamiento farmacológico , Técnicas Estereotáxicas , Resultado del Tratamiento , Infusiones IntraventricularesRESUMEN
BACKGROUND Hyperthermia is strongly associated with a worse neurological outcome in traumatic brain injury (TBI) and can be exacerbated by shivering. However, effective treatments for uncontrolled shivering have yet to be established. We successfully treated a patient with severe TBI and repeated episodes of shivering using dantrolene sodium hydrate (dantrolene). CASE REPORT A 28-year-old healthy male sustained an acute subdural hematoma with a midline shift following a traffic accident. He underwent emergency evacuation of the hematoma and craniectomy and was admitted to the Intensive Care Unit. The patient experienced severe shivering on the first day of hospitalization. Neuroprotective drugs were administered, and targeted temperature management at normothermia was initiated, initially controlling the shivering. On day 9 of hospitalization, shivering recurred, with a high fever. Despite the reintroduction of general anesthesia and targeted temperature management, the shivering was intractable. We administered dantrolene, which successfully eliminated the shivering. After the intervention, the patient's body temperature and intracranial pressure were well managed. The patient was subsequently transferred to a rehabilitation hospital, with a favorable neurological outcome 70 days after the injury. CONCLUSIONS This case report demonstrates that dantrolene is an effective option for managing uncontrollable shivering in the context of intracranial pressure control after severe brain injury. This finding suggests the potential for the broader use of dantrolene in similar clinical scenarios and supports further investigation of its efficacy and mechanisms of action in TBI care.
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Lesiones Traumáticas del Encéfalo , Dantroleno , Relajantes Musculares Centrales , Tiritona , Humanos , Dantroleno/uso terapéutico , Masculino , Adulto , Lesiones Traumáticas del Encéfalo/complicaciones , Relajantes Musculares Centrales/uso terapéuticoRESUMEN
OBJECTIVE: To study the histological changes in lung of rats, evaluate their dynamics and determine the Bax and Bcl-2 genes expression in bronchial epithelium, alveolar type 1 cells and neutrophils at different times after the administration of baclofen. MATERIAL AND METHODS: The experiment was conducted on 20 mature (at the age of 20 weeks) male Wistar rats with a mass of 290-350 g, distributed in 4 groups (5 rats in each). Animals in the control group did not receive baclofen. Rats in experimental groups received baclofen at a dose of 85 mg/kg: in the 1st group, the experiment duration was 3 hours (time to maximum observed blood drug concentration); in the 2nd group - 4.5 h (drug half-life and time to maximum observed concentration of the main drug's metabolite - beta-[p-chlorophenyl])-gamma-hydroxybutyric acid in the blood); in the 3rd group - 24 h. RESULTS: A complex of pathological reactions developed in lungs of experimental animals when baclofen muscle relaxant was administered, namely circulatory disturbances at all levels of the microvasculature (venular and capillary congestion, hemorrhages in the interalveolar septums, alveoli, sludge), emphysema, sites of which punctuated with atelectases and dystelectases. The complex of pathological changes in the lungs had a certain dynamics and reached its highest severity by the 24th hour. Bax expression was strong, while Bcl-2 expression was moderate in the immunohistochemical (IHC) study of bronchical epithelium and alveolar type 1 cells, Bax and Bcl-2 expression in neutrophils was moderate in rats of the 1st group. The expression of Bax and Bcl-2 was strong in the bronchial epithelium and alveolar type 1 cells, the expression of Bax in neutrophils was moderate, and BCL-2 - strong in animals of the 2nd group. The expression of Bax in bronchial epithelium and alveolar type 1 cells was moderate, expression of Bcl-2 in bronchial epithelium and alveolar type 1 cells - strong, expression of Bax in neutrophils - weak and expression of Bcl-2 - strong among the rats of the 3rd group. CONCLUSION: The complex of pathological changes in lungs had a certain dynamic. Data on the histological changes in lungs in combination with the results of the chemical study, can be used to diagnose the poisoning by baclofen and to establish the time since the drug was administered. The results obtained during the IHC study suggest the involvement of apoptosis in the development of lesion of bronchial epithelium and alveolar type 1 cells. In addition, the expression of Bcl-2 in epithelial cells may play a role in the process of their regeneration.
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Baclofeno , Pulmón , Neutrófilos , Proteínas Proto-Oncogénicas c-bcl-2 , Ratas Wistar , Proteína X Asociada a bcl-2 , Animales , Proteína X Asociada a bcl-2/metabolismo , Ratas , Proteínas Proto-Oncogénicas c-bcl-2/metabolismo , Neutrófilos/patología , Neutrófilos/efectos de los fármacos , Neutrófilos/metabolismo , Masculino , Baclofeno/farmacología , Pulmón/patología , Pulmón/efectos de los fármacos , Pulmón/metabolismo , Relajantes Musculares Centrales/farmacología , Alveolos Pulmonares/patología , Alveolos Pulmonares/efectos de los fármacos , Alveolos Pulmonares/metabolismoRESUMEN
CASE PRESENTATION: A woman in her 70s was found unresponsive and brought to our hospital with respiratory distress, cardiomyopathy and volatile alternation between hypotension and hypertension. She was intubated and admitted to intensive care for supportive treatment of suspected baclofen overdose. She gradually recovered and was discharged 10 days after presentation. Laboratory testing confirmed baclofen overdose. CONCLUSION: This case illustrates the classic features of baclofen toxicity but also includes unusual features including ST elevations on ECG and apical ballooning on echocardiogram. Lack of immediate laboratory testing can be a significant diagnostic challenge, so a high index of suspicion is needed to definitively diagnose baclofen overdose. Furthermore, haemodynamic volatility requires careful and frequent re-evaluation of treatment, so early recognition and anticipation of complications are essential for effective management of this life-threatening condition.
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Baclofeno , Sobredosis de Droga , Humanos , Baclofeno/envenenamiento , Femenino , Sobredosis de Droga/complicaciones , Anciano , Relajantes Musculares Centrales/envenenamiento , Electrocardiografía , EcocardiografíaRESUMEN
This study validates a stability-indicating LC method for detecting organic impurities in the chlorzoxazone dosage form. Using a Waters X-Select R HSS T3 analytical column, mobile phase of it was made by mixing of water, methanol, and glacial acetic acid in the ratio of 700:300:10 (v/v/v). The drug product and drug substance were subjected to the stress conditions such as acid, base, oxidation, heat, and photolysis as per the recommendations of the International Conference on Harmonization (Q2) methodology. The study revealed the susceptibility of 4-chloro-2-aminophenol to alkaline environments, emphasizing peak homogeneity and stability. The method verification, per ICH guidelines and USP<1225>, established precision, specificity, linearity, accuracy, and robustness for quality control. The mean impurity recovery ranged from 95.5% to 105.2%, the correlation coefficient (r) was greater than 1.000, and the RSD values (n = 6) ranged from 0.6% to 5.1% across the LOQ-150% ranges. Full-factorial design tested final method conditions, evaluating multiple parameters concurrently. Graphical optimization within the design space defined strong method requirements, ensuring consistent and reliable outcomes. The study develops and validates chlorzoxazone stability-indicating methods, employing advanced statistical approaches like design of experiments and factorial design, with resilient conditions established through graphical optimization of the design space.
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Clorzoxazona , Contaminación de Medicamentos , Estabilidad de Medicamentos , Relajantes Musculares Centrales , Clorzoxazona/química , Clorzoxazona/análisis , Reproducibilidad de los Resultados , Modelos Lineales , Relajantes Musculares Centrales/análisis , Relajantes Musculares Centrales/química , Límite de Detección , Cromatografía Líquida de Alta Presión/métodosRESUMEN
Importance: Stricter opioid prescribing guidelines have increased prescriptions of skeletal muscle relaxants (SMRs) for chronic pain, but the efficacy of long-term use of SMRs for chronic pain is unknown. Objective: To systematically review the effectiveness or efficacy of long-term use of SMRs for chronic pain. Evidence Review: Two reviewers systematically searched Ovid MEDLINE, Embase (Ovid), Web of Science, CINAHL, and Cochrane through December 4, 2023. They included articles published in English, Spanish, or Italian. Only randomized clinical trials (RCTs) and cohort studies with comparator groups evaluating at least 1-month duration of SMRs for chronic pain were included. The reviewers dually reviewed data abstraction, risk-of-bias, and quality. They characterized studies by chronic pain syndrome: low back pain, fibromyalgia, headaches, painful cramps or spasticity, and other syndromes. Findings: A total of 30 RCTs with 1314 participants and 14 cohort studies with 1168 participants assessed SMRs for chronic pain. Studies were primarily short-term (4-6 weeks). Nine unique SMRs were represented by the studies identified. Eleven studies (25%) examined baclofen, 8 (18%) examined tizanidine, and 7 (16%) examined cyclobenzaprine. Evidence for effectiveness was strongest for SMRs used for trigeminal neuralgia, neck pain, and painful cramps; evidence suggested SMRs for fibromyalgia, low back pain, and other syndromes were not more beneficial than placebo. The most common adverse effects were sedation and dry mouth. RCTs had a low to moderate risk of bias, and the quality of cohort studies was fair to good. Conclusions and Relevance: In this systematic review of long-term use of SMRs for chronic pain, findings suggest that their long-term use may benefit patients with painful spasms or cramps and neck pain; their long-term use for low back pain, fibromyalgia, and headaches did not appear to be beneficial. Clinicians should be vigilant for adverse effects and consider deprescribing if pain-related goals are not met.
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Dolor Crónico , Humanos , Dolor Crónico/tratamiento farmacológico , Relajantes Musculares Centrales/uso terapéuticoRESUMEN
STUDY DESIGN: Preclinical pilot study. OBJECTIVES: To explore peripheral and central nociceptive mechanisms that contribute to muscle stretch-induced locomotor deficits following spinal cord injury. SETTING: Kentucky Spinal Cord Injury Research Center, Louisville, KY, USA. METHODS: Ten female Sprague-Dawley rats received moderate, 25 g/cm T10 contusion injuries and recovered for 4 weeks. Rats were divided into three groups: Morphine/Ibuprofen-treated, Acetaminophen/Baclofen-treated, and saline control. Each group received daily hindlimb muscle stretching during weeks 4, 5, 9, and 10 post-injury and drugs were administered with stretching during weeks 4 and 9 only. Locomotor function was assessed throughout the experiment using the BBB Open Field Locomotor Scale. Hindlimb responses including spasticity, writhing, and clonic-like vibrations during muscle stretching were classified and scored. RESULTS: Consistent with our previous studies, hindlimb muscle stretching caused significant deficits in locomotor recovery following spinal cord injury. Baclofen and Ibuprofen partially mitigated the stretching effect, but none of the drugs significantly prevented the drop in locomotor function during stretching. Interestingly, treatment with Baclofen or Ibuprofen significantly reduced hindlimb responses such as spasticity and writhing during stretching, while Morphine exacerbated clonic-like vibrations in response to stretching maneuvers. CONCLUSIONS: These findings suggest that stretching may inhibit locomotor recovery through combined mechanisms of peripheral inflammation and sensitization of nociceptive afferents. When combined with central sprouting and loss of descending controls after SCI, this results in exaggerated nociceptive input during stretching. The inability of the applied clinical drugs to mitigate the detrimental effects of stretching highlights the complexity of the stretching phenomenon and emphasizes the need for further investigation.
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Modelos Animales de Enfermedad , Miembro Posterior , Ibuprofeno , Morfina , Ratas Sprague-Dawley , Traumatismos de la Médula Espinal , Animales , Femenino , Traumatismos de la Médula Espinal/fisiopatología , Traumatismos de la Médula Espinal/tratamiento farmacológico , Traumatismos de la Médula Espinal/complicaciones , Miembro Posterior/fisiopatología , Miembro Posterior/efectos de los fármacos , Ibuprofeno/farmacología , Ibuprofeno/administración & dosificación , Morfina/farmacología , Morfina/administración & dosificación , Ratas , Baclofeno/farmacología , Baclofeno/administración & dosificación , Acetaminofén/farmacología , Acetaminofén/administración & dosificación , Proyectos Piloto , Ejercicios de Estiramiento Muscular , Relajantes Musculares Centrales/farmacología , Relajantes Musculares Centrales/administración & dosificación , Analgésicos Opioides/farmacología , Analgésicos Opioides/administración & dosificaciónRESUMEN
INTRODUCTION: Spasticity is one of the most common secondary complications following a spinal cord injury (SCI), which can significantly debilitate a patient irrespective of the severity of the injury. Intrathecal baclofen therapy can effectively reduce global spasticity in bilateral lower extremities at lower doses and allows precise dose titration to manage spasticity optimally. In complex patients with spasticity and multiple medical comorbidities, multidisciplinary teamwork is required to assess ITB safety and deliver timely intervention to prevent secondary complications of spasticity and improve quality of life. CASE PRESENTATION: A 61-year-old African American male with multiple comorbidities, including end-stage renal disease (ESRD) requiring dialysis sustained non-traumatic SCI due to epidural abscess resulting in paraplegia and severe debilitating spasticity. Spasticity gradually worsened and interfered with his ability to achieve independence with functional activities appropriate for his neurological level of injury. A multidisciplinary team approach in this complex case resulted in a successful ITB trial and subsequent ITB implantation, resulting in reduced spasticity and improved quality of life. To our knowledge, this is the first case report of the administration of intrathecal baclofen pump therapy in a person with SCI and end-stage renal disease (ESRD) dependent on hemodialysis. DISCUSSION: ITB therapy can be safely delivered in a person with SCI and multiple medical comorbidities, including ESRD, dependent on hemodialysis to manage spasticity. However, a careful evaluation and discussion among the multidisciplinary team managing the patient's morbidities and patient is required to assess the risks and benefits of ITB therapy to allow the patient to make an informed decision.
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Baclofeno , Inyecciones Espinales , Fallo Renal Crónico , Relajantes Musculares Centrales , Espasticidad Muscular , Diálisis Renal , Traumatismos de la Médula Espinal , Humanos , Baclofeno/administración & dosificación , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Masculino , Persona de Mediana Edad , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/terapia , Traumatismos de la Médula Espinal/complicaciones , Relajantes Musculares Centrales/administración & dosificaciónRESUMEN
BACKGROUND: Cerebral palsy (CP) is the most cause of motor dysfunction in children. Selective dorsal rhizotomy (SDR) plays a major role in long term spasticity control. However, limited data exists on the effect of SDR on postoperative spasticity treatment requirements and supraspinal effects, and the stimulation responses of dorsal nerve roots in those with CP. METHODS: The current study included the outcome for 35 individuals undergoing SDR for motor functional outcome, spasticity, baclofen dose changes, botulinum toxin injection frequency, and spasticity related orthopedic procedures. We also report on the stimulation responses in 112 individuals who underwent SDR at our institution. RESULTS: There was a significant difference in gross motor function measures (GMFM)-66 scores at last follow up that remained present when considering only ambulatory children but not with non-ambulatory children. Ashworth scores were significantly decreased for both upper and lower extremities after SDR at all follow up points. There was a significant decrease in Baclofen dose and botulinum toxin injections requirements after SDR, but no significant difference in the need for orthopedic intervention. A total of 5502 dorsal nerve roots were tested showing a decrease in stimulation intensity and increase in grade on the right side and for descending lumbosacral levels. CONCLUSIONS: SDR improves gross motor scores during short term follow up but has additional benefits in decreasing baclofen dosing and botulinum toxin injections requirements after surgery. They stimulation responses of sectioned dorsal nerve roots adds to the limited available data and our understanding of the pathological changes that occur in CP.
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Parálisis Cerebral , Espasticidad Muscular , Rizotomía , Raíces Nerviosas Espinales , Parálisis Cerebral/cirugía , Humanos , Rizotomía/métodos , Masculino , Raíces Nerviosas Espinales/cirugía , Niño , Femenino , Espasticidad Muscular/cirugía , Espasticidad Muscular/tratamiento farmacológico , Resultado del Tratamiento , Adolescente , Baclofeno/administración & dosificación , Baclofeno/uso terapéutico , Preescolar , Relajantes Musculares Centrales/uso terapéutico , Relajantes Musculares Centrales/administración & dosificaciónRESUMEN
OBJECTIVE: The aim of this study was 1) to describe the rate of intrathecal baclofen (ITB)-associated complications at a large tertiary center, and 2) to evaluate the impact of patient-related factors on the likelihood of developing such complications. METHODS: A retrospective single-center study was carried out. A total of 301 eligible patients were included in the analysis. Univariate regression models were used to evaluate the impact of age, sex, diagnosis, ambulation status, modified Ashworth scale score, body mass index, diabetes status, and pain level on the likelihood of developing a device-related infection, pump malfunction, catheter malfunction, and other clinically significant complications. RESULTS: Overall, 27% of patients experienced an ITB-related complication. The most common complications included infection (6%, 18/301), pump malfunction (7.3%, 22/301), and catheter malfunction (14%, 42/301). The univariate analyses revealed that the patient's ambulatory status had a significant impact on the likelihood of developing a catheter-related malfunction. Furthermore, a trend toward significance was identified between patients' preoperative body mass index and device-related infection. Finally, the risk of suffering any ITB-related complications was statistically correlated with the number of years that had passed since the initial pump implantation. CONCLUSIONS: The authors' analysis reveals a previously underrecognized association between ambulatory status at the time of ITB pump implantation and the incidence of catheter-related complications, and confirms the impact of time since surgery on the risk of developing any ITB-related complication. The patient's age, sex, diagnosis, diabetes status, or pain level at baseline were not associated with the risk of complications. Collectively, these insights contribute novel information to the existing literature, providing practical value for physicians in guiding patient selection for ITB therapy.
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Baclofeno , Bombas de Infusión Implantables , Inyecciones Espinales , Relajantes Musculares Centrales , Humanos , Baclofeno/administración & dosificación , Baclofeno/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Adulto , Factores de Riesgo , Bombas de Infusión Implantables/efectos adversos , Relajantes Musculares Centrales/administración & dosificación , Relajantes Musculares Centrales/efectos adversos , Inyecciones Espinales/efectos adversos , Anciano , Adulto Joven , Espasticidad Muscular/tratamiento farmacológico , Falla de Equipo/estadística & datos numéricos , AdolescenteRESUMEN
OBJECTIVE: Intrathecal baclofen (ITB) pumps are commonly used in pediatric patients with cerebral palsy (CP) and medically refractory spasticity. However, catheter malfunction and associated risk factors are not well understood. The aim of this study was to examine potential risk factors for spinal catheter malfunction and characterize postoperative follow-up to understand the clinical consequences. METHODS: Patients who received ITB pump replacement or revision at Boston Children's Hospital between 2010 and 2023 were retrospectively reviewed. The spinal catheter revision cohort (SCRC) included patients whose spinal catheter was occluded requiring lumbar catheter revision. The second cohort included abdominal pump replacements only (APRC). Between-group comparisons and multivariable regression identified factors associated with catheter revision and postoperative outcomes. RESULTS: Forty-one (33.6%) patients underwent spinal catheter revision and were compared with 81 patients (66.4%) who underwent abdominal pump replacement only. Younger age at surgery and an elevated preoperative lower-extremity modified Ashworth scale grade were associated with spinal catheter revision (p < 0.05). Catheter model type, tip location, and history of spinal fusion were not associated with obstruction. Postoperatively, SCRC patients experienced a higher rate of infection (17.1%) relative to APRC patients (0%) within 30 days from their ITB pump replacement procedure (p < 0.05) and greater likelihood of subsequent ITB system removal compared with the APRC (24.4% vs 7.4%, p < 0.05). Although not differing preoperatively, SCRC patients had lower postoperative ITB doses when compared with the APRC group (median dose 143 vs 350 µg/day, p < 0.05) at hospital discharge and remained statistically different at the 6-month and 1-year follow-ups (p < 0.05). There were no postoperative differences in baclofen overdose, withdrawal, or median number of hospital readmissions within 30 days. Overall, 31.7% of spinal catheter revisions were unanticipated by the clinical team at time of surgery. CONCLUSIONS: Younger age at surgery and increased preoperative lower-extremity tone may be risk factors for catheter obstruction, resulting in a higher rate of postoperative infection and subsequent ITB pump removal compared with pump replacement alone. Spinal catheter occlusion can complicate revision or replacement procedures, especially when unanticipated. Routine clinical assessment may be inadequate for diagnosing insidious catheter malfunction. Catheter occlusion deserves further study, and routine assessment of catheter patency may be warranted to prevent suboptimal tone therapy.
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Baclofeno , Parálisis Cerebral , Bombas de Infusión Implantables , Relajantes Musculares Centrales , Humanos , Baclofeno/administración & dosificación , Baclofeno/efectos adversos , Masculino , Femenino , Niño , Bombas de Infusión Implantables/efectos adversos , Factores de Riesgo , Relajantes Musculares Centrales/administración & dosificación , Estudios Retrospectivos , Adolescente , Parálisis Cerebral/cirugía , Parálisis Cerebral/complicaciones , Preescolar , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Espasticidad Muscular/cirugía , Reoperación/métodos , Inyecciones Espinales/métodos , Resultado del Tratamiento , Complicaciones Posoperatorias/etiología , Falla de Equipo , Estudios de CohortesAsunto(s)
Baclofeno , Parálisis Cerebral , Inyecciones Espinales , Espasticidad Muscular , Rizotomía , Humanos , Parálisis Cerebral/complicaciones , Parálisis Cerebral/cirugía , Rizotomía/métodos , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/cirugía , Espasticidad Muscular/etiología , Baclofeno/administración & dosificación , Baclofeno/uso terapéutico , Niño , Inyecciones Espinales/métodos , Relajantes Musculares Centrales/administración & dosificación , Relajantes Musculares Centrales/uso terapéuticoRESUMEN
OBJECTIVE: The purpose of this systematic review was to evaluate empirical outcomes of studies in the literature that investigated effectiveness of intrathecal baclofen (ITB) in the treatment of multiple sclerosis (MS)-related spasticity (MSRS) based on various metrics. Since the first description of this route of baclofen delivery for MS patients by Penn and Kroin in 1984, numerous studies have contributed to the medical community's knowledge of this treatment modality. The authors sought to add to the literature a systematic review of studies over the last 2 decades that elucidates the clinical impact of ITB in treating MSRS with the following endpoints: impact on patient-centered outcomes, such as spasticity reduction (primary), complications (secondary), and dosing (secondary). METHODS: The authors queried three databases (PubMed, Scopus, and Cochrane Library) using the following search terms: (intrathecal baclofen) AND (multiple sclerosis). The set inclusion criteria were as follows: 1) original, full-text article; 2) written in the English language; 3) published between and including the years 2000 and 2023; 4) discussion of pre- and post-ITB pump implantation outcomes (e.g., reduction in spasticity and improved comfort) in MSRS patients with long-term ITB treatment; and 5) contained a minimum of 5 MS patients. Data on study type, patient demographics, follow-up periods, primary outcomes, and secondary outcomes were extracted from the included studies. RESULTS: The authors' search yielded 465 studies, of which 17 met inclusion criteria. Overall, they found evidence for the effectiveness of ITB in treating MSRS patients whose condition was refractory to oral medications, with significant reported changes in spasm frequency from pre- to postimplantation. They also found evidence supporting the positive impact of ITB on MSRS patients' quality of life. Moreover, the authors found that most complications were surgical rather than pharmacological. In addition, the average 1-year dose of ITB (reported in 7 of the included studies) was 191.93 µg/day, which is substantially lower than ITB doses reported in the literature for patients with central (non-MS) or spinal origins of spasticity at 1-year follow-up. CONCLUSIONS: The evidence supports ITB as a clinically effective treatment for MSRS, particularly in patients in whom oral antispasmodics and physiotherapy have failed. This systematic review contributes a comprehensive synthesis of clinical benefits, complications, and dosing of ITB reported over the past 2 decades, which furthers an understanding of ITB's clinical utility in practice.
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Baclofeno , Inyecciones Espinales , Esclerosis Múltiple , Relajantes Musculares Centrales , Espasticidad Muscular , Baclofeno/administración & dosificación , Humanos , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple/complicaciones , Inyecciones Espinales/métodos , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Relajantes Musculares Centrales/administración & dosificación , Resultado del TratamientoRESUMEN
OBJECTIVE: Intrathecal baclofen (ITB) is an effective treatment for hypertonia in children involving the implantation of a pump and catheter system. The highest concentration of ITB is at the catheter tip. The catheter tip location is most commonly within the lumbar or thoracic spine. The cervical tip location has traditionally been avoided because of concerns of hypoventilation and pneumonia; however, these complications in cervical compared with thoracic or lumbar placement have not been reliably proven. Some studies have suggested that cervical ITB location better treats upper-extremity hypertonia. There are limited data describing the safety and efficacy of cervical ITB on hypertonia. The authors present a single-institution retrospective case series highlighting the safety and efficacy of using cervical ITB location for the treatment of hypertonia. METHODS: Retrospective data analysis was performed for children who underwent continuous dosing cervical ITB between April 2022 and October 2023. Nonmodifiable risk factors, clinical variables, operative characteristics, and adverse outcomes were collected. RESULTS: This study included 25 patients (8 female). The mean age at implantation was 12.4 years, and the mean operative duration was 90 minutes. The mean Barry-Albright Dystonia Scale score decreased by 9.5 points (p = 0.01). The mean aggregated modified Ashworth scale score in the upper extremities decreased by 2.14 points (p = 0.04), and that in the lower extremities decreased by 4.98 points (p < 0.01). One patient each (4%) had infection and baclofen toxicity. Two patients (8%) had respiratory depression requiring continuous positive airway pressure. There was no incidence of pneumonia or wound dehiscence. CONCLUSIONS: The cervical catheter tip location for ITB is safe, is effective to control tone, and should be considered for the treatment of hypertonia. Larger studies with longer follow-up are necessary to further determine upper-limit dosing safety along with long-term functional benefits in these patients.
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Baclofeno , Inyecciones Espinales , Relajantes Musculares Centrales , Humanos , Baclofeno/administración & dosificación , Femenino , Estudios Retrospectivos , Masculino , Niño , Inyecciones Espinales/métodos , Adolescente , Relajantes Musculares Centrales/administración & dosificación , Resultado del Tratamiento , Preescolar , Hipertonía Muscular/tratamiento farmacológico , Bombas de Infusión Implantables/efectos adversos , Vértebras Cervicales/cirugíaRESUMEN
BACKGROUND: The first pump for intrathecal administration of baclofen was implanted in 1984. Over thirty years, intrathecal prolonged infusion of muscle relaxants has occupied a worthy niche among all methods for correction of non-focal drug-resistant disabling muscle spasticity. However, this method has not become routine despite high awareness of specialists in Russia and abroad, as well as undeniable advantages for restoring the daily activity, improving the walking pattern and providing care and quality of life in people with limited mobility. This is due to scrupulous analysis of adverse events and accurate attitude towards its use.The purpose of this review was to systematize data on indications, selection criteria, pump implantation technique, subsequent patient management and treatment outcomes over a 30-year history. METHOD: A review of national and foreign literature was performed. RESULTS AND CONCLUSION: Prolonged intrathecal baclofen therapy is perspective for long-term treatment of severe spasticity interfering with quality of life and self-care if oral muscle relaxants are contraindicated or ineffective. This procedure is effective for impaired articulation, chewing and spastic pain syndrome. One can reduce the incidence of side effects via correct dosage of the drug, and tolerance to therapy can be reduced by timely elimination of problems with catheter.
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Baclofeno , Inyecciones Espinales , Relajantes Musculares Centrales , Espasticidad Muscular , Baclofeno/administración & dosificación , Baclofeno/uso terapéutico , Humanos , Espasticidad Muscular/tratamiento farmacológico , Inyecciones Espinales/métodos , Relajantes Musculares Centrales/administración & dosificación , Bombas de Infusión Implantables , Calidad de VidaRESUMEN
Malignant hyperthermia (MH) is a fatal hyperthermia with a high mortality, which usually occurs during induction of general anesthesia. Dantrolene sodium is a wonder drug currently used for treating malignant hyperthermia. However, preparing, storing, and maintaining dantrolene sodium are crucially expensive, thus making it financially unsatisfactory and difficult for clinicians to acquire in time. Monitoring patients' condition closely and intervening promptly when early signs of malignant hyperthermia occur can effectively prevent the condition from worsening and win over time for the arrival of dantraline sodium. This article is to report a case in which we successfully rescued a child occurring malignant hyperthermia without using dantrolene sodium.
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Anestesia General , Dantroleno , Hipertermia Maligna , Relajantes Musculares Centrales , Preescolar , Humanos , Dantroleno/uso terapéutico , Relajantes Musculares Centrales/uso terapéuticoRESUMEN
INTRODUCTION: This case report presents the management of a 62-year-old woman with generalized grade 4 tetanus, focusing on the innovative use of intrathecal baclofen (ITB) therapy. The patient initially presented with a laceration and subsequently developed severe tetanic spasms, necessitating interventions beyond standard tetanus immunoglobulin and antibiotics due to the condition's progressive and life-threatening nature. The preference for ITB over oral baclofen is highlighted, considering ITB's enhanced bioavailability in the central nervous system and its efficacy in reducing spinal cord reflexes, which is critical for managing severe spasticity.On her return to the emergency department with symptoms of tetanus, the patient received ITB following the failure of oral baclofen to control the spasms. ITB administration necessitated a lumbar drain, which was later substituted with a tunneled intrathecal catheter due to the extended requirement for baclofen infusion and the unavailability of suitable infusion pumps. This scenario represented a significant application of a CADD-Solis external pump for continuous ITB infusion.Transitioning the patient from ITB to oral baclofen was a crucial management step to facilitate discharge and recovery, underscoring the importance of a careful approach to prevent withdrawal symptoms and maintain care continuity. Despite initial complications, including an infection signaled by leucocytosis and confirmed through cerebrospinal fluid culture, the patient was effectively treated and discharged. CONCLUSION: This report contributes to the sparse literature on prolonged ITB use for generalized grade 4 tetanus treatment, underlining the need for interdisciplinary collaboration for the best patient outcomes. It showcases the potential of ITB in spasticity management, in reducing the need for sedation, and in shortening the duration of mechanical ventilation, advocating for a tailored approach that utilizes a full spectrum of pharmacological and supportive therapies.