Not yet recruiting NCT06935552

Ketamine and Lidocaine Infusion in Refractory Chronic Migraine

Early Phase I Interventional Refractory Chronic Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Ketamine infusion, Lidocaine Intravenous Infusion, Dextrose 5% in water.
Who it may be relevant to: Registry conditions: Refractory Chronic Migraine. Basic parameters: 18 years — 60 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Ketamine and Lidocaine Infusion for Refractory Chronic Migraine: Comparative Study

Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study

Drug Ketamine infusion
group A will receive ketamine intravenous infusion
Drug Lidocaine Intravenous Infusion
group B will receive lidocaine intravenous infusion
Drug Dextrose 5% in water
group C will only receive Dextrose 5% in water

Changes in pain scale using Numeric rating scale [Time frame: From enrollment to the end of treatment at 6 weeks]
Changes in pain scale using Migraine disability assessment [Time frame: From enrollment to the end of treatment at 6 weeks]

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Center list to be confirmed — check the primary protocol.

Schulman EA, Lake AE 3rd, Goadsby PJ, Peterlin BL, Siegel SE, Markley HG, Lipton RB. Defining refractory migraine and refractory chronic migraine: proposed criteria from the Refractory Headache Special Interest Section of the American Headache Society. Headache. 2008 Jun;48(6):778-82. doi: 10.1111/j.1526-4610.2008.01132.x. Epub 2008 May 14. PMID 18484982
Ray JC, Cheng S, Tsan K, Hussain H, Stark RJ, Matharu MS, Hutton E. Intravenous Lidocaine and Ketamine Infusions for Headache Disorders: A Retrospective Cohort Study. Front Neurol. 2022 Mar 9;13:842082. doi: 10.3389/fneur.2022.842082. eCollection 2022. PMID 35356451
Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese. PMID 19378524
Kohrs R, Durieux ME. Ketamine: teaching an old drug new tricks. Anesth Analg. 1998 Nov;87(5):1186-93. doi: 10.1097/00000539-199811000-00039. No abstract available. PMID 9806706
Natoli JL, Manack A, Dean B, Butler Q, Turkel CC, Stovner L, Lipton RB. Global prevalence of chronic migraine: a systematic review. Cephalalgia. 2010 May;30(5):599-609. doi: 10.1111/j.1468-2982.2009.01941.x. PMID 19614702

NCT: NCT06935552 · ketamine vs lidocaine in RCM