Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07408193
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or more
* Capacity to provide informed consent, ability to complete study assessments and comply with the study procedures
* Meets the IASP definition for chronic cancer-related pain
* Moderate or severe pain, defined as average pain of 4 or greater on an 11-point (0-10) NRS in the past 24h
* Adequate trial of opioid medication, defined as a dose of at least 60 mg/day oral morphine equivalent or maximum tolerated dose, in the past 24h
* For patients with neuropathic component to pain: adequate trial of at least one adjuvant analgesic, defined as a daily dose of at least Amitriptyline 37.5mg, Duloxetine 30mg, Gabapentin 900mg, Pregabalin 150mg, Venlafaxine 60mg or equivalent (26), or maximum tolerated dose in the past 24h
Exclusion Criteria:
* Previous adverse reaction to ketamine, lidocaine or other amide-type local anesthetics, midazolam
* Severe liver disease (Child Class B or C)
* SGPT or SGOT \>5 times the upper limit of normal
* End stage kidney disease
* Serious cardiac comorbidity (e.g. unstable angina, poorly controlled hypertension or tachycardia, high-risk coronary vascular disease, symptomatic heart failure with NYHA class III-IV, history of heart block, Wolf-Parkinson-White syndrome, Adams-Stokes syndrome)
* Elevated intracranial or intraocular pressure
* Pheochromocytoma or poorly controlled hyperthyroidism
* History of psychosis, schizophrenia or substance abuse
* Pregnant or breastfeeding
* Porphyria
* Life expectancy shorter than the duration of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07408193
Study Brief:
Protocol Section:
NCT07408193