Impact of pharmacogenomics and metabolism on the effectiveness and toxicity of racemic ketamine in palliative care and chronic pain patients
Evaluation of the clinical pharmacology and pharmacogenomics of ketamine in palliative care patients and chronic pain patients
Andrew Somogyi
50 participants
Oct 17, 2012
Interventional
Conditions
Summary
The primary purpose is to determine whether the effectiveness of ketamine and its toxicity are related to the circulating plasma concentrations of ketamine and/or its active metabolite norketamine. The study hypothesis is that there is a plasma concentration window for ketamine, below which it is ineffective to control pain and above which it produces adverse effects, and that the concentration is dependent on the patient's genotype for CYP2B6
Eligibility
Inclusion Criteria4
- Able to be commenced on ketamine based on clinical grounds for refractory cancer or other pain.
- Fluent in english language.
- Able to participate in the monitoring of pain and adverse effects
- Males and females over 18 years
Exclusion Criteria3
- Patients with poor venous access
- patients in whom significant hypertension or tachycardia would be potentially dangerous
- Adverse reaction to ketamine in the past
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Interventions
Ketamine 24 hour continuous intravenous infusions of 100 (day 1), 300 (day 2) and 500 mg (day 3) per day over a total of 3 days in palliative medicine and 5 days (500 mg/day on day 4 and 5) in chronic pain patients. Total intervention is a maximum of 5 days. Blood samples collected to assess pharmacokinetics, metabolism to norketamine, CYP2B6 genetic polymorphisms. Relationship between plasma concentrations and a) pain scores and b) adverse effects
Locations(1)
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ACTRN12613000327785