Impact of pharmacogenomics and metabolism on the effectiveness and toxicity of racemic ketamine in palliative care and chronic pain patients

Phase 3

Completed

• Conditions: Chronic pain patients; Anaesthesiology - Pain management

• Registration Number: ACTRN12613000327785
• Lead Sponsor: Andrew Somogyi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship of plasma ketamine and/or norketamine concentrations to efficacy of pain attenuation (pain scores 100 mm VAS) and adverse effects (NCI Criteria especially psychotomimetic)[Day 3]

Secondary Outcome Measures

Name	Time	Method
Relationship of CYP2B6 polymorphism (*6 variant) to plasma ketamine and norketamine concentrations (LC-MS assay) using gene-dose test (Jonckheere-Terpstra) ; [end of days 1, 2 and /or 3]