Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow (NCT01567345) | Clinical Trial Compass
CompletedNot Applicable
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow
France54 participantsStarted 2009-01-14
Plain-language summary
The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> or = 18 years old.
* Patient with advanced cancer.
* Patient with severe pain, i.e. a mean daily pain score \> or = 5 on an numeric rating scale.
* Failure of optimal conventional analgesic therapy : either due to intolerable adverse events or to lack of efficacy, i.e. after having tried opioid rotation techniques, different way of administration, use of rapid-acting narcotics to control acute episodes of pain, use of intravenous morphine by PCA pump.
* Possibility of return home
* Dated and signed informed consent form.
Exclusion Criteria:
* Patient's refusal to participate in the study.
* Ongoing pregnancy.
* Ongoing systemic infection.
* Injection site infection.
* Estimated survival less than 90 days.
* Allergy or intolerance to morphine.
* Contraindication to implantation of an intrathecal catheter.
* Patient treated with a powerful CYP1A2 inhibitor, such as fluvoxamine or enoxacin.
* Intrathecal chemotherapy planned.