Ketamine and Lidocaine Infusion in Refractory Chronic Migraine

NCT ID: NCT06935552

Last Updated: 2025-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-12-31

Brief Summary

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Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study

Detailed Description

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Conditions

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Refractory Chronic Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketamine

will receive ketamine

Group Type EXPERIMENTAL

Ketamine infusion

Intervention Type DRUG

group A will receive ketamine intravenous infusion

Lidocaine

will receive lidocaine

Group Type EXPERIMENTAL

Lidocaine Intravenous Infusion

Intervention Type DRUG

group B will receive lidocaine intravenous infusion

Dextrose

Group Type PLACEBO_COMPARATOR

Dextrose 5% in water

Intervention Type DRUG

group C will only receive Dextrose 5% in water

Interventions

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Ketamine infusion

group A will receive ketamine intravenous infusion

Intervention Type DRUG

Lidocaine Intravenous Infusion

group B will receive lidocaine intravenous infusion

Intervention Type DRUG

Dextrose 5% in water

group C will only receive Dextrose 5% in water

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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AbdElRahman Mohamed Mohamed Mohamed

Resident doctor in neurology and psychiatry department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nageh Fouly Kamel, PhD.

Role: STUDY_CHAIR

Assiut University

Mohamed Ahmed Abdelhameed, PhD.

Role: STUDY_CHAIR

Assiut University

Central Contacts

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AbdElRahman Mohamed Mohamed

Role: CONTACT

+201066586931

References

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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.

Reference Type BACKGROUND
PMID: 18484982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35356451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19378524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9806706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19614702 (View on PubMed)

Other Identifiers

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ketamine vs lidocaine in RCM

Identifier Type: -

Identifier Source: org_study_id

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