Migraine Headache With Intractable Migraine Clinical Trial
Official title:
Ketamine for Refractory Chronic Migraine: a Pilot Study
Verified date | March 2020 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Ketamine is a drug used for anesthesia but at low doses it is a very effective pain reliever in several chronic conditions. Preliminary studies have shown that ketamine might be effective for patients with refractory chronic migraine, which is a severe type of headache for which patients usually have tried and failed many medications and can cause severe disability to their lives. This study will evaluate ketamine prospectively when given to patients who have "failed" an initial inpatient treatment.
Status | Completed |
Enrollment | 6 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult patients (age 18 years and older) who meet the criteria of refractory chronic migraine as defined by the International Classification of Headache Disorders-II definition who present to the Jefferson Headache Center after failing an inpatient course of treatment at Methodist. Exclusion Criteria: - Schizophrenia - active psychosis - pregnancy - poorly controlled cardiovascular disease - cirrhosis - previous treatment with intravenous ketamine These criteria are all consistent with the 2018 Consensus Guidelines for Ketamine. Patients who are deemed poor candidates for ketamine by a study team member for any reason, such as intolerance of prior neuroleptic medications, may be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
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Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The improvement in pain after ketamine (0 to 10 numerical rating scale) will be compared to improvement after initial inpatient treatment. | Each patient will serve as his or her own control. | 1 year | |
Primary | Improvement in a 0-3 qualitative scale where 0=none, 1=mild, 2=moderate, 3=severe pain will be used comparing change from beginning to end of ketamine treatment to change after initial inpatient treatment. | Each patient will serve as his or her own control. | 1 year | |
Secondary | Incidence of adverse effects | The number and severity of adverse effects, including hallucinations, nightmares, nausea/vomiting, blurry vision, sedation, and changes in liver function tests, will be recorded. | 1 year | |
Secondary | Ketamine metabolite levels | Levels of ketamine metabolites, including norketamine, hydroxynorketamines, hydroxyketamines, and dehydronorketamines, will be measured at baseline, 24 h, 48 h, 72 h, and just before infusion is stopped. | 1 year |