Intrathecal S(+)-ketamine is a potent option in the treatment of chronic severe neuropathic pain in cancer patients refractory to conventional therapeutic strategies (Benrath et al. 2005). However, the lack of systematic safety data limit the neuraxial administration of S(+)-ketamine. Benrath J, Scharbert G, Gustorff B, Adams HA, Kress HG. Long-term intrathecal S(+)-ketamine in a patient with cancer-related neuropathic pain. Br J Anaesth 2005
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: 1-22525
CAS Number: unknown
Current Sponsor code: 20061
Other descriptive name: S(+)-ketamine hydrochloride
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Vienna Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: chronic, refractory, neuropathic cancer pain Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: contraindications against ketamine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Previous case reports of post-mortem histopathological findings after the use of different ketamine preparations showed controversial results. If continuous intrathecal administration of S(+)-ketamine without preservatives would induce severe histopathological abnormalities in the spinal cord and nerve roots, behavioral or clinical signs of neurotoxicity would be anticipated. The aim of this study is to perform a detailed neurological and behavioral follow up in cancer patients requiring long-term intrathecal S(+)-ketamine as a last resort when other options have failed.;Secondary Objective: ;Primary end point(s): any change in neurology and behaviour during S(+)-ketamine administration | — |
Countries
Austria
Outcome results
None listed