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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000327785

Enrollment

Registered

2013-03-25

Start date

2012-10-17

Completion date

2014-03-27

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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 criteria

Patients with poor venous access patients in whom significant hypertension or tachycardia would be potentially dangerous Adverse reaction to ketamine in the past

Outcome results