Ketamine and Lidocaine Infusion in Refractory Chronic Migraine

Early Phase 1

Not yet recruiting

• Conditions: Refractory Chronic Migraine
• Interventions: Drug: Ketamine infusion; Drug: Lidocaine Intravenous Infusion; Drug: Dextrose 5% in water

• Registration Number: NCT06935552
• Lead Sponsor: Assiut University

Brief Summary

Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-06-01
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine infusion	will receive ketamine
Lidocaine	Lidocaine Intravenous Infusion	will receive lidocaine
Dextrose	Dextrose 5% in water	-

Primary Outcome Measures

Name	Time	Method
Changes in pain scale using Numeric rating scale	From enrollment to the end of treatment at 6 weeks	Pain assessment by using a Numeric rating scale (0 (no pain) to 10 (worst possible pain). Scores of 1-3 are considered mild, 4-6 moderate, and 7-10 severe) before the infusion and daily for 1-week post infusion, then weekly for 6 weeks post infusion
Changes in pain scale using Migraine disability assessment	From enrollment to the end of treatment at 6 weeks	Migraine disability assessment test before the infusion and daily for 1-week post infusion, then weekly for 6 weeks post infusion