Open AccessIntrathecal Administration of I nfumorph ® vs Compounded Morphine for Treatment of Intractable Pain Using the P rometra ® Programmable Pump
Author(s) -
Rosen Steven M.,
Bromberg Todd A.,
Padda Gurpreet,
Barsa John,
Dunbar Elmer,
Dwarakanath Gopala,
Navalgund Yesh,
Jaffe Todd,
Yearwood Thomas L.,
Creamer Michael,
Deer Timothy
Publication year - 2013
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/pme.12077
Subject(s) - medicine , morphine , anesthesia , infusion pump , adverse effect , dosing , opiate , crossover study , population , intractable pain , opioid , pharmacology , receptor , alternative medicine , environmental health , pathology , placebo
Objectives. The intrathecal administration of morphine sulfate has become an established alternative to oral opiate therapy for the treatment of chronic pain. Currently, I nfumorph ® is the only morphine sulfate approved by the US F ood and D rug A dministration 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 I nfumorph 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 P rometra programmable pump. Results. The mean drug delivery accuracy using only I nfumorph 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 I nfumorph 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. The P rometra system accurately delivers both I nfumorph 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.