Accuracy and efficacy of intrathecal administration of morphine sulfate for treatment of intractable pain using the Prometra® Programmable Pump

Rauck, Richard; Deer, Timothy R.; Rosen, Steven T.; Padda, Gurpreet S.; Barsa, J.; Dunbar, Elmer E.; Dwarakanath, Gopala

doi:10.1111/j.1525-1403.2009.00257.x

Cited by 54 publications

(41 citation statements)

References 20 publications

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“…Reliability and accuracy of intrathecal therapy drives success, both pharmacokinetically and pharmacodynamically . Intrathecal drug delivery may be plagued by historical patient selection dogma, failure of accurate, reliable delivery, and iatrogenic error.…”

Section: Resultsmentioning

confidence: 99%

Intrathecal Pharmacology Update: Novel Dosing Strategy for Intrathecal Monotherapy Ziconotide on Efficacy and Sustainability

Pope

Deer²

2015

Neuromodulation: Technology at the Neural Interface

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Section: Resultsmentioning

confidence: 99%

Intrathecal Pharmacology Update: Novel Dosing Strategy for Intrathecal Monotherapy Ziconotide on Efficacy and Sustainability

Pope

Deer²

2015

Neuromodulation: Technology at the Neural Interface

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“… 12–14 An in vivo study in sheep 13 showed larger average flow-rate error and a smaller SD (9.32% [SD, 9.27%]) in individual refill measurements than either the current study or the 2 studies cited above. Investigators in the sheep study were able to weigh the pump volumes input and the residual volumes, which may be more accurate than the syringe-read volumetric measurements used in the present clinical study.…”

Section: Discussionmentioning

confidence: 49%

Clinical Accuracy and Safety Using the SynchroMed II Intrathecal Drug Infusion Pump

Wesemann¹,

Coffey

Wallace

et al. 2014

Regional Anesthesia and Pain Medicine

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Background and ObjectivesWe evaluated the infusion accuracy and device-related safety of implantable drug infusion pumps in subjects with chronic pain or severe spasticity.MethodsNine centers in the United States enrolled patients receiving intrathecal drug delivery systems to manage chronic pain and/or severe spasticity. Infusion accuracy was assessed at 6 and 12 months by comparing syringe-measured delivered volumes to programmer-predicted volumes. Safety was evaluated through analysis of adverse events. Separate laboratory testing conducted by the manufacturer also evaluated infusion accuracy.ResultsEighty of 82 enrolled subjects were implanted. Sixty-five and 54 subjects, respectively, were analyzable for accuracy at 6 and 12 months. On average at 6 months, the pumps were measured to have delivered 1% more than the programmed delivery volume. Analyzed on a per-refill basis, the pumps delivered, on average, 2.5% more than the programmed delivery volume. Differences between per-refill means versus per-subject cumulative means were due to limitations in clinicians’ ability to precisely visualize single small syringe-volume differences, or possibly incomplete withdrawal of fluid from the pump. Laboratory testing demonstrated a per-refill mean accuracy error of minus 2.4%. Because average observed flow-rate error at 6 and 12 months (1% overinfusion) was derived from pump residual volume measurements by syringe and carried out in a clinical setting, clinical volume ratios were larger than direct volume measurements by weight observed in the laboratory. No deaths, permanent injuries, or unanticipated adverse device effects occurred.ConclusionsThe pump accurately delivered intrathecal medication in the clinical setting of this study. Adverse events were similar in nature and severity to those described in the product labeling and literature.

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“…The Prometra I system by Flowonix was demonstrating an accuracy of 97.1%, with a 90% confidence interval of 96.2-98.0%, with follow-up of 6 and 12 months [93, 94]. The Medtronic Synchromed II pump has had issues with accuracy, including challenges with off-label medicines and combination therapy regarding motor stall and gear corrosion with the peristaltic mechanism of delivery [95].…”

Section: Discussionmentioning

confidence: 99%

The Pharmacology of Spinal Opioids and Ziconotide for the Treatment of Non-Cancer Pain

Pope¹,

Deer²,

Amirdelfan³

et al. 2017

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BackgroundIntrathecal drug delivery has undergone a revitalization following a better understanding of this delivery route and its pharmacokinetics. Driven by patient safety and outcomes, clinicians are motivated to rethink the traditional spinal infusion pump patient selection criteria and indications. We review the current understanding of the pharmacology of commonly employed intrathecal agents and the clinical relevance.MethodsSearch strategies for data acquisition included Medline database, PubMed, Google scholar, along with international and national professional meeting content, with key words including pharmacology of opioids, intrathecal therapy, ziconotide, pharmacokinetics, and intrathecal drug delivery. The search results were limited to the English language.ResultsOver 300 papers were identified. The literature was condensed and digested to evaluate the most commonly used medications in practice, sto serve as a foundation for review. We review on-label medications: ziconotide and morphine, and off label medications including fentanyl, sufentail, and hydromorphine.ConclusionIntrathecal therapy has level-one evidence for use for malignant pain and nonmalignant pain, with continued cost savings and improved safety. To most effectively serve our patients, a clear appreciation for the pharmacology of these commonly employed medication is paramount..

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Accuracy and efficacy of intrathecal administration of morphine sulfate for treatment of intractable pain using the Prometra® Programmable Pump

Cited by 54 publications

References 20 publications

Intrathecal Pharmacology Update: Novel Dosing Strategy for Intrathecal Monotherapy Ziconotide on Efficacy and Sustainability

Intrathecal Pharmacology Update: Novel Dosing Strategy for Intrathecal Monotherapy Ziconotide on Efficacy and Sustainability

Clinical Accuracy and Safety Using the SynchroMed II Intrathecal Drug Infusion Pump

The Pharmacology of Spinal Opioids and Ziconotide for the Treatment of Non-Cancer Pain

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