Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy

Hoving, Marjanke A.; Raak, E.P.M. van; Spincemaille, G.H.; Kranen-Mastenbroek, Vivianne H.J.M. van; Kleef, Maarten van; Gorter, Jan Willem; Vles, Johan S.H.

doi:10.1016/j.ejpn.2008.05.002

Cited by 52 publications

(64 citation statements)

References 20 publications

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“…This suggests that ITB therapy may contribute to the improvement of secondary pain by controlling the spasticity 6 and GABA-mediated analgesic modulation. 10 In summary, we estimated the response with a baclofen infusion pump using the test dose of ITB bolus injection in a patient with ambulatory CP who had spasticity, musculoskeletal pain, and gait disturbance.…”

Section: Discussionmentioning

confidence: 98%

“…Vital signs such as blood pressure, heart rate, and respiratory rate, and adverse events were monitored after the procedure (Table 1). 6 Although there was no improvement in terms of the MAS for grading spasticity, discomforts the patient experienced at the initiation of gait were subjectively improved and the pain in the lower back and posterior thigh were markedly reduced ( Table 2). The next day, the patient received 25 μg of ITB, and video-based observational gait analysis was performed at 4 hours after the procedure.…”

Section: Case Reportmentioning

confidence: 99%

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Dose-dependent Changes in Gait Pattern after Intrathecal Baclofen Bolus Injection in Adult Ambulatory Cerebral Palsy: A Case Report

et al. 2015

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Intrathecal baclofen (ITB) therapy has been proven to reduce severe spasticity in cerebral palsy (CP). However, few results reported the objective gait pattern change after ITB bolus injection in adult ambulatory CP. We therefore evaluated observational and kinematic gait patterns at different ITB bolus injection doses. We performed a test trial of 3-day ITB bolus injections at doses of 12.5 μg, 25 μg, and 50 μg in ambulatory CP. We evaluated modified Ashworth scale, visual analogue scale, observational gait scale, and kinematic gait analysis after ITB bolus injection. Intrathecal administration of low-dose baclofen 25 μg was successfully used not only for the treatment of spasticity but also for the treatment of gait disturbance, whereas the higher dose baclofen 50 μg induced foot drop and deteriorated gait pattern. We experienced dose-dependent changes in gait pattern confirmed by the observational and kinematic gait assessments after ITB bolus injection in adult ambulatory CP.

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Section: Discussionmentioning

confidence: 98%

Section: Case Reportmentioning

confidence: 99%

Dose-dependent Changes in Gait Pattern after Intrathecal Baclofen Bolus Injection in Adult Ambulatory Cerebral Palsy: A Case Report

et al. 2015

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“…However, ITB trials might be useful in ambulant patients and those with complex hyperkinetic movement disorders, where benefits of ITB therapy are less well documented. The ITB trial may remain a useful tool to help patients/families make an informed decision, particularly given the high rate of complications from baclofen pumps 2,9,14,16,[18][19][20]24,27 and the long-term commitment to meticulous follow-up for pump refills. Additionally, the level of response to the test dose guides the initial ITB daily infusion rate, usually calculated as twice the effective trial dose.…”

Section: Discussionmentioning

confidence: 99%

“…It works as an agonist of the inhibitory neurotransmitter g-aminobutyric acid. 10 Unfortunately, its effectiveness when taken orally is limited due to poor crossing of the blood-brain barrier, leading to high doses being required to combat spasticity or dystonia and concomitant side effects.Intrathecal baclofen (ITB) has been used since the 1980s for treatment of high tone, especially in the lower limbs.2,11 Pump delivery systems allow a patient to receive lower doses of baclofen at a constant rate with fewer side effects than the enteral route.5 Placement of an ITB pump is an invasive procedure associated with significant complications; 2,9,14,16,[18][19][20]24,27 therefore, high-quality patient selection is vital. A common stage of a presurgical workup for the ITB pump is the delivery of an ITB test dose.…”

mentioning

confidence: 99%

“…2,11 Pump delivery systems allow a patient to receive lower doses of baclofen at a constant rate with fewer side effects than the enteral route. 5 Placement of an ITB pump is an invasive procedure associated with significant complications; 2,9,14,16,[18][19][20]24,27 therefore, high-quality patient selection is vital. A common stage of a presurgical workup for the ITB pump is the delivery of an ITB test dose.…”

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confidence: 99%

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Intrathecal baclofen trials: complications and positive yield in a pediatric cohort

Sayer

Lumsden

Perides

et al. 2016

PED

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OBJECT Intrathecal baclofen (ITB) is an effective management option for childhood hypertonia. Given the potential complications of implanted ITB pumps, trials of ITB are usually performed as part of the workup for ITB pumps. Two methods are used for ITB trials, lumbar puncture (LP) and catheter insertion into the intrathecal space. Little has been written to date on the number of positive trials and complications in trials. This study aimed to report the outcomes and complications in ITB trials for childhood hypertonia (dystonia, spastic, or mixed). METHODS A retrospective case notes review was conducted of all patients who underwent ITB trials at the Evelina London Children’s Hospital between 2005 and 2012 (inclusive). Positive trials were defined as a reduction in Modified Ashworth Scale by a minimum of 1 point in at least 2 muscle groups and improvement reported by the caregivers in the areas of goals agreed upon between professionals and the families. RESULTS Our patient group comprised children with dystonia (n = 7), mixed spasticity/dystonia (n = 29), spasticity (n = 4), and pain (n = 1). A total of 47 trials were attempted in 41 children. Forty trials were successfully completed, with 39 being positive. Thirty-three were catheter trials, and 14 were LPs. The overall complication rate in the 47 attempted trials was 53%: 61% in catheter trials, and 36% in LP trials. This difference was not statistically significant. The most common complications were vomiting (n = 9) and CSF leak (n = 4). The most serious complication was meningitis (n = 1) in a catheter trial. No patients experienced a permanent injury. CONCLUSIONS There is a high risk of minor self-limiting complications with ITB trials, which needs to be factored into the decision process of progression to trials. The rate of positive trials in this study was 98%, of which 21% did not progress to pump implantation. While the authors would still advocate for ITB trials prior to ITB pump insertion to aid parental decision-making, this figure suggests that with good patient selection, ITB pumps could be placed without a preceding trial.

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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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Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy

Cited by 52 publications

References 20 publications

Dose-dependent Changes in Gait Pattern after Intrathecal Baclofen Bolus Injection in Adult Ambulatory Cerebral Palsy: A Case Report

Dose-dependent Changes in Gait Pattern after Intrathecal Baclofen Bolus Injection in Adult Ambulatory Cerebral Palsy: A Case Report

Intrathecal baclofen trials: complications and positive yield in a pediatric cohort

Intrathecal baclofen for treating spasticity in children with cerebral palsy

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