Intrathecal Baclofen for Management of Spastic Cerebral Palsy: Multicenter Trial

Gilmartin, Richard; Bruce, Derek A.; Storrs, Bruce B.; Abbott, Rick; Krach, Linda E.; Ward, John D.; Bloom, Karen; Brooks, William H.; Johnson, Dennis L.; Madsen, Joseph R.; McLaughlin, John F.; Nadell, Joseph M.

doi:10.1177/088307380001500201

Cited by 230 publications

(125 citation statements)

References 11 publications

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“…This has also been reported by other authors. 3 For our patients, the average dose at which the test was considered to be effective was higher when the spasticity was of cerebral origin. This has not been previously reported, probably because most tests used 100 mg as maximal dose.…”

Section: Bolus Test Proceduresmentioning

confidence: 74%

“…Two-thirds of cerebral palsy children are epileptic and it has been shown that ITB does not modify the occurrence of fits. 3,36,39 Recently, 40 EEG data were obtained in a patient with multiple sclerosis and major overinfusion. Generalized discharges were noted until the 20th hour and then decreased in parallel with clinical improvement.…”

Section: Pharmacological Side Effectsmentioning

confidence: 99%

“…3,43 The use of refill kits, including bacteria filters, has decreased their incidence. 37,44 The perioperative antibioprophylaxis, suggested by some authors, 28,29 is not yet established.…”

Section: Pharmacological Side Effectsmentioning

confidence: 99%

“…Its first indication was chronic, medically intractable spasticity of spinal origin. 1,2 Indications have been extended to spasticity of other origins, 3,4 to dystonia, 5 and more recently to the treatment of early vegetative dysfunction in traumatic brain injury. 6,7 Spasticity is defined by Lance as a velocity-dependent increase in muscle tone with exaggerated tendon jerk resulting from hyperexcitability of the stretch reflex.…”

Section: Introductionmentioning

confidence: 99%

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Treatment of spasticity with intrathecal Baclofen administration: long-term follow-up, review of 40 patients

et al. 2004

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Study design: Case series of a consecutive sample. Retrospective audit. Objective: To analyze the long-term safety and efficacy of intrathecal baclofen (ITB), and technical incidents. Setting: Neurosurgical and Physical Medicine Departments of two university hospitals in western France. Methods: The medical records of 40 patients who underwent ITB pump placement for the treatment of severe chronic spasticity were reviewed. Patients were eligible independently of the origin of the spasticity (spinal cord origin 33, brain damage 8). They underwent a final assessment with clinical examination and questionnaire in 2001. Ashworth scale scores were assessed, patient satisfaction was rated on a visual analog scale (VAS), functional independence before and after treatment was classified as bed-ridden, wheelchair dependant or ambulant, and the frequency and nature of complications were noted. Results: The average follow-up period was of 4 years. The average Ashworth score at the final assessment was 1.870.6. Average patients satisfaction was 7.4/1072.21 on VAS. In all, 85% would have undergone the procedure again if they had to make the decision. In 85% of the cases the ambulation status was unchanged. Technical incidents occured at least once in 37% of the patients (due to the catheter in 58% and to the pump in 42%). They included catheter disconnections (4), migration (4), kinks (3), obstruction (3), development of fibrosis (3), disconnection of pump reservoir (2), porosity of pump membrane (2), unexplained pump dysfunction (4) leakage, and subcutaneous collection (5). Severe pharmacological side effects requiring transfer to intensive care unit occured in 12% of cases, 80% of which were directly related to pump refill procedures. Conclusion: ITB remained effective in the long term and patients were satisfied. Nevertheless, complications were frequent, involving mainly the catheters, which would require further technical improvements.

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Section: Bolus Test Proceduresmentioning

confidence: 74%

Section: Pharmacological Side Effectsmentioning

confidence: 99%

Section: Pharmacological Side Effectsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Treatment of spasticity with intrathecal Baclofen administration: long-term follow-up, review of 40 patients

et al. 2004

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“…Doses are further increased to 80 µg-800 µg·day -1 (average need 150 µg·day -1 ) according to the patient's muscle tone and the side effects. 3 After the effective dose of intrathecal baclofen has been established in an individual patient, a permanent programmable pump device can be implanted into the abdominal subcutaneous tissue.…”

mentioning

confidence: 99%

The Panomat® P-10 micro-volumetric infusion pump is suitable for continuous drug administration at minimal flow rates

Neff

Fellmann

Fuechslin³

et al. 2002

Can J Anesth/J Can Anesth

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P Pu ur rp po os se e: : To evaluate the performance of the Panomat® P-10 micro-volumetric infusion pump for its use in drug administration at minimal flow rates (µL·hr -1 ; e.g., intrathecal application).M Me et th ho od ds s: : Fluid delivery at steady state conditions, and after vertical displacement of the syringe pump by -50 cm was determined gravimetrically. The Panomat® P-10 infusion pump was evaluated at 4, 10, 20, 50 and 100 µL·hr -1 , and compared to a conventional syringe pump assembly at 100, 200, 500 and 1000 µL·hr -1 . Measurements were repeated twice with two different devices of each syringe pump system, and with two syringes. Data are reported as mean ± SD. R Re es su ul lt ts s: : Steady state fluid delivery of the Panomat® P-10 infusion pump revealed less than 5% deviation to set flow rate at 10, 20, 50 and 100 µL·hr -1 , and 12% deviation at 4 µL·hr -1 . Mean zero-drug delivery time (ZDDT) after lowering the pump by 50 cm at 4 µL·hr -1 flow rate was 38.4 ± 7.3 min. At 100 µL·hr -1 and with original infusion line ZDDT was almost 20 times shorter when compared to the conventional syringe pump assembly (1.5 ± 0.5 min vs 28.5 ± 5.0 min). C Co on nc cl lu us si io on n: : The tested Panomat® P-10 micro-volumetric pump shows an acceptable flow accuracy as well as a low susceptibility to vertical displacement, and is therefore suitable for continuous drug administration at minimal flow rates. The technology used in this pump carries potential implications for a new generation of syringe pumps. (1,5 ± 0,5 min vs 28,5 ± 5,0 min Objectif

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Intrathecal baclofen for treating spasticity in children with cerebral palsy

Hasnat

Rice

2015

Cochrane Database of Systematic Reviews

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There is some limited short-term evidence that intrathecal baclofen is an effective therapy for reducing spasticity in children with cerebral palsy. The effect of intrathecal baclofen on long-term spasticity outcomes is less certain.The validity of the evidence for the effectiveness of intrathecal baclofen in treating spasticity in children with cerebral palsy from the studies in the review is constrained by the small sample sizes of the studies and methodological issues in some studies.Spasticity is a impairment in the domain of body structure and function. Consideration must also be given to the broader context in determining whether intrathecal baclofen therapy is effective. The aim of therapy may be, for example, to improve gross motor function, to increase participation at a social role level, to improve comfort, to improve the ease of care by others or to improve the overall quality of life of the individual. Intrathecal baclofen may improve gross motor function in children with cerebral palsy, but more reliable evidence is needed to determine this.There is some evidence that intrathecal baclofen improves ease of care and the comfort and quality of life of the individuals receiving it, but again small sample sizes and methodological issues in the studies mean that these results should be interpreted with caution.Further evidence of the effectiveness of intrathecal baclofen for treating spasticity, increasing gross motor function and improving comfort, ease of care and quality of life is needed from other investigators in order to validate these results.The short duration of the controlled studies included in this review did not allow for the exploration of questions regarding whether the subsequent need for orthopaedic surgery in children receiving intrathecal baclofen therapy is altered, or the safety and the economic implications of intrathecal baclofen treatment when long-term therapy is administered via an implanted device. Controlled studies are not the most appropriate study design to address these questions, cohort studies may be more appropriate.

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Intrathecal Baclofen for Management of Spastic Cerebral Palsy: Multicenter Trial

Cited by 230 publications

References 11 publications

Treatment of spasticity with intrathecal Baclofen administration: long-term follow-up, review of 40 patients

Treatment of spasticity with intrathecal Baclofen administration: long-term follow-up, review of 40 patients

The Panomat® P-10 micro-volumetric infusion pump is suitable for continuous drug administration at minimal flow rates

Intrathecal baclofen for treating spasticity in children with cerebral palsy

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