Ketamine and Lidocaine Infusion in Refractory Chronic Migraine

Assiut University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Refractory Chronic Migraine

Treatments: Drug: Ketamine infusion; Drug: Lidocaine Intravenous Infusion; Drug: Dextrose 5% in water

Study type: Interventional

Funder types: Other

Identifiers

NCT06935552

ketamine vs lidocaine in RCM

Details and patient eligibility

About

Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants must fulfill the following inclusion criteria

  1. medically stable outpatients with confirmed diagnosis of refractory chronic migraine according to American Headache society
  2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
  3. Men or women older than 18years of age.
  4. clear written informed consent from each participant in the trial.
  5. Adult patients with refractory migraine or refractory chronic migraine defined according to the American headache society

Exclusion criteria

1. Pregnancy, active psychosis, liver disease, uncontrolled cardiac disease or cardiac rhythm abnormalities
2. presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study
3. participation in any other type of medical research that may interfere with the interpretation of the study.
4. patients with hemocoagulation disorders, local infection or those who refused to consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 3 patient groups, including a placebo group

Ketamine

Experimental group

Description:

will receive ketamine

Treatment:

Drug: Ketamine infusion

Lidocaine

Experimental group

Description:

will receive lidocaine

Treatment:

Drug: Lidocaine Intravenous Infusion

Dextrose

Placebo Comparator group

Treatment:

Drug: Dextrose 5% in water