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NCT Number: NCT06935552

Ketamine and Lidocaine Infusion in Refractory Chronic Migraine

Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study

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Key information

Conditions

Refractory Chronic Migraine

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants must fulfill the following inclusion criteria
  • medically stable outpatients with confirmed diagnosis of refractory chronic migraine according to American Headache society
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
  • Men or women older than 18years of age.
  • clear written informed consent from each participant in the trial.
  • Adult patients with refractory migraine or refractory chronic migraine defined according to the American headache society

Exclusion criteria

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

Treatment and study plan

ketamine infusion

Drug

group A will receive ketamine intravenous infusion

Lidocaine Intravenous Infusion

Drug

group B will receive lidocaine intravenous infusion

Dextrose 5% in water

Drug

group C will only receive Dextrose 5% in water

Primary outcomes

  1. Changes in pain scale using Numeric rating scale

    Time frame: 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

  2. Changes in pain scale using Migraine disability assessment

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

AbdElRahman Mohamed Mohamed

CONTACT

[email protected]

+201066586931

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ketamine and Lidocaine Infusion for Refractory Chronic Migraine: Comparative Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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