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At least 991 records · Page 55Linked to original sources
PubMed2006

Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life.

OBJECTIVES: To evaluate the impact of intrathecal baclofen (ITB) on function and quality of life (QOL) and to obtain efficacy and safety data in poststroke spastic hypertonia. DESIGN: Prospective open-label multicenter trial with follow-up at 3 and 12 months. SETTING: Twenty-four stroke treatment centers in the United States. PARTICIPANTS: Ninety-four stroke participants (age range, 24-82 y) with spastic hypertonia. Seventy-four participants underwent ITB pump implantation. INTERVENTION: Participants were implanted with an ITB pump. MAIN OUTCOME MEASURES: FIM instrument and QOL (Sickness Impact Profile [SIP]) changes, spastic hypertonia (Ashworth Scale), and safety. RESULTS: FIM scores improved overall in repeated-measures analysis of variance (ANOVA) (P = .005) and by 3.00 +/- 7.69 (P = .001) at 3 months and by 2.86 +/- 10.13 (P = .017) at 12 months. Significant improvements in SIP scores were noted overall (repeated-measures ANOVA, P < .001) and at 3 (P = .003) and 12 months (P < .001). The combined average Ashworth Scale score of the upper and lower limbs decreased by 1.27 +/- 0.76 (P < .001) at 3 months and by 1.39 +/- 0.73 (P < .001) at 12 months from baseline, which was significant overall (repeated-measures ANOVA, P<.001). Strength in the unaffected side did not change overall (repeated-measures ANOVA, P = .321) or at either 3 (P = .553) or 12 months (P = .462). Minimal adverse events and device complications were reported. CONCLUSIONS: There was significant improvement in function, QOL, and spastic hypertonia at 3 and 12 months after implant, without adversely affecting muscle strength of the unaffected limbs. Data suggest that ITB therapy is a safe and efficacious treatment for spastic hypertonia resulting from stroke.

Activities of Daily Living↗
PubMed2006

Dose-response relationship between the H-reflex and continuous intrathecal baclofen administration for management of spasticity.

OBJECTIVE: To determine the relationship between the H-reflex (H/M ratio) and continuous intrathecal baclofen (CITB) dose after pump implantation for control of spastic hypertonia. METHODS: Soleus H-reflexes were serially recorded in 34 subjects (19 men, mean age 32 years, mean follow-up 1.7 years) during simple continuous mode of CITB delivery. Different fitting methods were explored to determine which function best described changes in H/M ratio with increasing CITB dose. We then calculated effective CITB doses yielding H/M ratios equal to 75, 50, and 25% (ED75, ED50, ED25) of the baseline recorded before the implant in 22 subjects. RESULTS: We found a significant dose-response relationship between the soleus H/M ratio and CITB dose. A two-decay exponential function was the best fit on each side for pooled data, but a general linear model when controlling for subject. The mean ED75, ED50, ED25 were 30, 70, and 110 mcg/day. Logistical regression predicted with high probability that the H/M ratio should be less than 30% at CITB doses above 150 mcg/day. CONCLUSIONS: H/M ratio is strongly dependent on CITB dose. It sharply decreases up to 150 mcg/day of CITB followed by a plateau. SIGNIFICANCE: Establishing the relationship between the H/M ratio and CITB dose may be useful for dose titration and early identification of an ITB system malfunction.

Adolescent↗
PubMed2004

Baclofen toxicity in an 8-year-old with an intrathecal baclofen pump.

Baclofen delivered by intrathecal pumps (ITB) is increasingly being utilized in the pediatric population, however, resources and education to support problems with these devices are limited. Typical management strategies for systemic baclofen overdose include removal of baclofen from the device reservoir or removal of cerebrospinal fluid from the adjacent device catheter. Appropriate care of these patients requires awareness of the clinical patterns of toxicity and mechanics of the ITB pump delivery system. This report describes the clinical presentation, unfamiliar dilemmas, and the management of a pediatric patient with intrathecal baclofen toxicity, noting problems that may arise in the care of these patients.

Baclofen↗
PubMed2004

Stability of clonidine in clonidine-hydromorphone mixture from implanted intrathecal infusion pumps in chronic pain patients.

Clonidine is frequently added to opioids in implantable intrathecal pumps for the management of chronic pain. In such devices, a small non-retrievable volume is always present in the reservoir, and its effect on drug stability is unknown. Furthermore, stability of clonidine, when mixed with hydromorphone, has not been previously determined. This study examined the stability of clonidine when co-administered with hydromorphone in implanted intrathecal pumps. Samples of hydromorphone-clonidine before pump refill and from residual solution at subsequent refill were obtained from chronic pain patients. Clonidine concentration was measured using HPLC. Twenty paired samples from 3 patients were analyzed. All 3 patients had a SynchroMed pump implanted for 3-5 years. We found no loss in clonidine concentration during the time between refills (35 +/- 13 days), and no correlation between clonidine concentration and time interval between refills. In conclusion, clonidine, mixed with hydromorphone, is stable when delivered by implantable intrathecal pump for long-term use.

Analgesics↗
PubMed2004

Stability of admixture containing morphine sulfate, bupivacaine hydrochloride, and clonidine hydrochloride in an implantable infusion system.

Intrathecal infusion is often performed using drug combinations. This study was conducted to evaluate the stability of the admixture of morphine sulfate, bupivacaine hydrochloride, and clonidine hydrochloride when used in an implantable pump under simulated clinical use conditions. SynchroMed implantable pumps were filled with an admixture and incubated at 37 degrees C for a period of 90 days. Drug admixture stored in glass vials at 4 degrees C and at 37 degrees C served as controls. Samples which included pump reservoir and catheter delivered aliquots were collected every 30 days and analyzed for drug concentrations using a stability-indicating HPLC method. All drugs contained in the admixture were stable and the original concentrations remained greater than 96%. Over 90 days, and with the pump at the simulated body temperature of 37 degrees C, there were no evident heat catalyzed or device catalyzed reactions.

Analgesics↗
PubMed2004

Intrathecal opioid treatment for chronic non-malignant pain: a 3-year prospective study.

Intrathecal (IT) opioid therapy is a treatment alternative for patients with severe chronic non-malignant pain. Several uncontrolled retrospective and prospective outcome studies have suggested a benefit in chronic non-malignant pain patients, but uncertainties about patient selection in these studies weaken the results. This study evaluated long-term outcome of IT opioid therapy in chronic non-malignant pain prospectively, and included two comparative groups to improve understanding of selection criteria and relative severity of intrathecal pump recipients (PRs). The study subjects included 38 PRs while the comparative groups included 31 intrathecal candidates who either had an unsuccessful trial, or declined the IT therapy, and another group of 41 newly referred patients. The following data were analyzed at study entry, and at 6 monthly intervals for a 3-year period: Symptom Check List 90 (SLC-90), SF-36 Health survey, Beck Depression Inventory, McGill Pain Questionnaire (short form), Oswestry Disability Index, Pain Drawings and Pain rating on visual analogue scale. Data analysis suggests the study group of PRs had improvements in pain, mood, and function from baseline to 36 months. These same parameters improved among new referrals (less severe patients receiving conservative pain management) while non-recipients significantly worsened. Although PRs improved, they were still worse off at 36 months than new referrals were at baseline. The study showed that when patients with extremely severe pain problems are selected as pump candidates, they will likely improve with the therapy, but their overall severity of pain and symptoms still remains high.

Activities of Daily Living↗
PubMed2005

Intraparenchymal migration of an intrathecal catheter three years after implantation.

Intrathecal drug administration using implanted catheter and pump systems has been used in routine clinical practice for more than 20 years to treat chronic refractory pain or spasticity. Complications associated with the use of these systems include drug related adverse events as well as technical problems, most of which are related either to the catheter or the procedure. Although traumatic neural damage is exceedingly rare it is usually associated with significant neurological impairment. We present a case of asymptomatic intraspinal migration of an intrathecal catheter three years after an uneventful implantation. To the best of our knowledge, this complication has never been reported before.

Catheterization↗
PubMed2004

Hip status in cerebral palsy after one year of continuous intrathecal baclofen infusion.

The purpose of this study was to assess whether reduction of muscle tone by continuous intrathecal baclofen infusion affects the progression of hip subluxation in persons with cerebral palsy. This prospective, open-label, case series was conducted at multiple specialty referral centers. There were 33 subjects, ages 4 to 31 years. All had a pretreatment lower extremity Ashworth score of >/=3; all subjects had a significant reduction in tone after a bolus injection of intrathecal baclofen and received an implanted pump for continuous delivery of intrathecal baclofen. Subjects had hip x-rays before and 1 year after pump implantation. The primary outcome measure was change in absolute hip migration percentage. One third of the hips had an increase of absolute migration percentage of 5% or more; 12% of the hips had a decrease of migration percentage of 5% or more. Change of migration percentage class was used as a second outcome criterion. 90.9% of hips manifested no deterioration or had improvement of their migration percentage class during the year of intrathecal baclofen therapy. The observed changes were not associated with the subject's age or the severity of cerebral palsy.

Adolescent↗
PubMed2005

Epilepsy and intrathecal baclofen therapy in children with cerebral palsy.

The objective of this study was to analyze the relationship between epilepsy and intrathecal baclofen by investigating a consecutive sample of 150 children with cerebral palsy or spasticity of cerebral origin who underwent intrathecal baclofen. The medical charts of the 150 children were retrospectively reviewed. A series of 100 children with cerebral palsy, operated on other procedures, was reviewed as a control group. Forty percent of the 150 children had epilepsy before intrathecal baclofen pump implantation; 13.3% had a decrease in seizure frequency after intrathecal baclofen, while two children worsened and one child had seizures ex novo. We conclude that in children with spasticity of cerebral origin, intrathecal baclofen does not seem to aggravate or induce seizure activity.

Baclofen↗
PubMed2002

Neurologic complications including paralysis after a medication error involving implanted intrathecal catheters.

PURPOSE: Long-term continuous intrathecal infusion of medications for chronic medical problems is common. We investigated the cause of a cluster of severe neurologic complications in patients with intrathecal catheters. METHODS: We performed an epidemiologic cohort study of patients who had intrathecal catheters in place in one neurosurgical practice, to assess the presence of new neurologic complications and associated risk factors. RESULTS: The practice included 61 patients who received pain medication through implanted intrathecal catheter pumps, 19 of whom were treated with morphine, either alone or in combination with other medications. None of the 42 patients whose drug regimen did not include morphine developed a complication, whereas 8 of 13 patients who received morphine in refills of their pumps during one 4-week period experienced neurologic complications. Three persons underwent laminectomy for sterile abscesses and were left with new paralysis or leg weakness. Testing of two stock bottles from the involved pharmacy, both labeled as containing pure morphine, revealed the presence of methadone in addition to morphine. One of these bottles also contained trace ethanol. A sample of medication aspirated from the pump of a patient prescribed morphine from the same pharmacy was also found to have contained methadone and methanol. CONCLUSIONS: A variety of severe neurologic complications was associated with inadvertent administration of methadone, and perhaps other unintended substances, by means of implanted intrathecal catheters to a group of patients. Medical errors in an outpatient pharmacy led to this outbreak.

Adult↗
PubMed2003

Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study.

OBJECTIVE: To explore whether intrathecal baclofen (ITB) therapy improves ambulation in stroke survivors. DESIGN: Case series. SETTING: Tertiary care center. PARTICIPANTS: Ten adults with poststroke hemiparesis who were ambulatory at the time of pump implantation. INTERVENTIONS: Implantation of ITB pump after inadequate control of spasticity with other interventions. Time from stroke onset to implantation averaged 28.6 months (range, 9-55mo). MAIN OUTCOME MEASURES: Customary walking speed was measured from the time required to walk 50ft (15m) at a self-selected pace. Evaluators rated spastic hypertonia and functional mobility. RESULTS: Statistically significant improvements occurred in walking speed, functional mobility ratings, and spasticity (P<.05) at a follow-up interval that averaged 8.9 months. Mean walking speed over 50ft improved from 36.6 to 52cm/s. Mean Modified Ashworth Scale scores in the muscles of the affected lower limb improved from 2.0 to 0.4. Normal muscle strength (5/5) was preserved in the unaffected limbs. CONCLUSIONS: This preliminary study suggests that ITB therapy, in combination with physical therapy, may improve walking speed and functional mobility in ambulatory individuals with poststroke spastic hemiplegia.

Adult↗
PubMedDate not supplied

Effect of iron chelation therapy on mortality in Zambian children with cerebral malaria.

To examine the effect of iron chelation on mortality in cerebral malaria, we enrolled 352 children in a trial of deferoxamine in addition to standard quinine therapy at 2 centres in Zambia, one rural and one urban. Entrance criteria included age < 6 years, Plasmodium falciparum parasitaemia, normal cerebral spinal fluid, and unrousable coma. Deferoxamine (100 mg/kg/d infused for a total of 72 h) or placebo was added to a 7 d regimen of quinine that included a loading dose. Mortality overall was 18.3% (32/175) in the deferoxamine group and 10.7% (19/177) in the placebo group (adjusted odds ratio 1.8; 95% confidence interval 0.9-3.6; P = 0.074). At the rural study site, mortality was 15.4% (18/117) with deferoxamine compared to 12.7% (15/118) with placebo (P = 0.78, adjusted for covariates). At the urban site, mortality was 24.1% (14/58) with deferoxamine and 6.8% (4/59) with placebo (P = 0.061, adjusted for covariates). Among survivors, there was a non-significant trend to faster recovery from coma in the deferoxamine group (adjusted odds ratio 1.2; 95% confidence interval 0.97-1.6; P = 0.089). Hepatomegaly was significantly associated with higher mortality, while splenomegaly was associated with lower mortality. This study did not provide evidence for a beneficial effect on mortality in children with cerebral malaria when deferoxamine was added to quinine, given in a regimen that included a loading dose.

Antidotes↗
PubMed1997

Intrathecal granuloma after implantation of a morphine pump: case report and review of the literature.

BACKGROUND: Intrathecal morphine pumps are being increasingly used in patients with benign pain who have a longer life expectancy than cancer patients. Newer complications may be encountered. CLINICAL PRESENTATION: We report a complication that occurred in a 48-year-old woman who presented with intractable lower back pain 18 months after morphine pump implantation. Magnetic resonance imaging of the lumbosacral spine revealed an intrathecal mass around the catheter. At surgery, an inflammatory mass was found without any evidence of neoplasia or infection. This is a very unusual complication of intrathecal morphine pumps. (Related animal and human studies are reviewed in this article.) CONCLUSION: Long-term use of implantable pumps may carry increased risks that are not observed during the short-term experience of cancer patients. Reimaging is important in evaluating patients who have developed uncontrollable pain and new neurologic findings.

Analgesics, Opioid↗
PubMedDate not supplied

Cost-effectiveness of long-term intrathecal morphine therapy for pain associated with failed back surgery syndrome.

A decision analytic study was conducted using computer simulation to project the outcomes in a simulated cohort of patients whose treatment for back surgery had failed. The objective of this study was to estimate the direct cost of intrathecal morphine therapy (IMT) delivered via an implantable pump relative to alternative therapy (medical management) over a 60-month course of treatment. IMT administered by way of an implantable pump can provide effective pain relief for selected patients whose less invasive treatment modalities have failed. Previous research suggested that a pump implant is less costly than alternative methods providing comparable analgesia for treatment exceeding 12 to 18 months. However, those analyses did not include the cost of complications or pump replacement. Scenarios representing the course of IMT, devised by a panel of experts, were represented as treatment pathways in a Monte Carlo simulation. Adverse event rates were drawn from published data supplemented by expert judgment. Direct costs were based on a health insurer paid claims perspective (direct costs) discounted at a 5% annual rate. The cost-effectiveness of IMT was calculated based on a report of 65% to 81% "good to excellent" pain relief relative to alternative (medical) management. With both adverse event probabilities and costs set at most likely (base case) values, the expected total cost of IMT over 60 months was $82,893 (an average of $1382 per month). In a sensitivity analysis, the best case (low adverse event rate, low cost) estimate was $53,468 ($891/mo), whereas the worst case (high adverse event rate, high cost) estimate was $125,102 ($2085/mo). Cost-effectiveness estimates ranged from $7212 (best case) to $12,276 (worst case) per year of pain relief. Results from a computer simulation designed to collect the costs not included in previous empiric research indicate that IMT appears to be cost-effective when compared with alternative (medical) management for selected patients when the duration of therapy exceeds 12 to 22 months.

Back↗
PubMed2001

Mechanical hyperalgesia in rats with chronic perfusion of lumbar dorsal root ganglion with hyperglycemic solution.

In diabetes, chronic systemic hyperglycemia is associated with pain and other symptoms of peripheral neuropathy. Evaluation of mechanisms causing these symptoms is complicated because of the overlap between the systemic effects of hyperglycemia and its toxic effects within the peripheral nervous system. To address this problem we developed a technique for chronic local in vivo perfusion of rat lumbar dorsal root ganglion (DRG) with a hyperglycemic solution. Osmotic pumps were filled with 30 mM glucose in physiological buffer and implanted in normal adult rats. The output of the catheter attached to the pump was positioned in a hole drilled through the right transverse process of the L(5) vertebrae to perfuse the corresponding DRG. Repetitive tests of foot withdrawal to mechanical stimuli have shown that chronic hyperglycemia localized to the L(5) DRG causes hyperalgesia in the hind limb innervated by perfused ganglion but not in the contralateral limb. Control experiments (DRG perfusion with 5 mM glucose or 5 mM glucose+25 mM mannitol solution) have shown that hyperglycemia-induced hyperalgesia can not be attributed to surgery-related injury or hyperosmolality of the ganglion-perfusing solution. These data demonstrate direct functional toxicity of hyperglycemia in the peripheral nervous system. This technique provides a new approach for in vivo study of chronic effects of physiologically active factors on DRG neuron function.

Animals↗