Intrathecal administration of Infumorph® vs compounded morphine for treatment of intractable pain using the Prometra® programmable pump

Pain Med. 2013 Jun;14(6):865-73. doi: 10.1111/pme.12077. Epub 2013 Apr 9.

Abstract

Objectives: The intrathecal administration of morphine sulfate has become an established alternative to oral opiate therapy for the treatment of chronic pain. Currently, Infumorph(®) is the only morphine sulfate approved by the US Food and Drug Administration for continuous intraspinal administration with an infusion pump. However, in order to achieve and maintain adequate pain relief, patients may require concentrations outside of those commercially available products resulting in the use of compounded morphine.

Methods: Accuracy, safety, and efficacy data related to Infumorph and compounded morphine use were collected during clinical trials of a new implantable pump. This report compares those results in a total of 154 subjects implanted with the Prometra programmable pump.

Results: The mean drug delivery accuracy using only Infumorph in 31 subjects was 100.1% and was comparable with the accuracy reported for the 71 subjects who received only compounded morphine sulfate (97.4%). The percentage of subjects free from device-related serious adverse events (DRSAEs) was similar in both groups. Compounded morphine showed statistically significant improvements in pain and disability, where Infumorph only showed a statistical improvement in pain. Dosing was higher in the compounded group. Results are also presented for a crossover group that received both types of morphine.

Conclusions: ThePrometra system accurately delivers both Infumorph and compounded morphine with no significant differences in DRSAE rates. These results indicate that compounded morphine delivery effectively treats the chronic pain patient population. Higher doses appear to provide better pain relief; however, optimal pain relief will need to be balanced against the risk of granuloma formation.

Publication types

  • Comparative Study
  • Controlled Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Dose-Response Relationship, Drug
  • Drug Compounding
  • Drug Therapy, Computer-Assisted / instrumentation*
  • Drug Therapy, Computer-Assisted / methods
  • Equipment Design
  • Equipment Failure Analysis
  • Female
  • Humans
  • Infusion Pumps*
  • Injections, Spinal / instrumentation*
  • Injections, Spinal / methods
  • Male
  • Middle Aged
  • Morphine / administration & dosage*
  • Morphine / classification
  • Pain Measurement / drug effects*
  • Pain, Intractable / diagnosis*
  • Pain, Intractable / drug therapy*
  • Treatment Outcome
  • United States

Substances

  • Morphine