Clinical trial NCT06935552: Ketamine and Lidocaine Infusion in Refractory Chronic Migraine
Official title: Ketamine and Lidocaine Infusion for Refractory Chronic Migraine: Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Refractory Chronic Migraine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study


Eligibility criteria: 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

Primary outcomes:
measure: Changes in pain scale using Numeric rating scale
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Changes in pain scale using Migraine disability assessment
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Nageh Fouly Kamel, PhD.
role: STUDY_CHAIR
affiliation: Assiut University
name: Mohamed Ahmed Abdelhameed, PhD.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.