Real-world study of intranasal ketamine for use in patients with refractory chronic migraine

Abstract

Subanesthetic ketamine infusion has been used for managing refractory headache in inpatient or outpatient infusion settings. Intranasal (IN) ketamine may be an alternative option for outpatient care. We performed a retrospective study at a single tertiary headache center to assess the clinical effectiveness and tolerability of IN ketamine in patients with refractory chronic migraine (rCM). Candidates who received IN ketamine between January 2019 and February 2020 were screened through an electronic medical record query. Manual chart reviews and structured phone interviews were conducted upon obtaining informed consent. Among 242 subjects screened, 169 (age 44.3 ± 13.8; female 79.9%) were interviewed. They reported 25.0 ± 8.7 monthly headache days and tried 6.9 ± 3.1 preventive medications. Overall, they used roughly 7.8 ± 7.0 sprays (ie., 78 mg) per day and 11.6 ± 8.9 days per month. Intranasal ketamine was reported as "very effective" in 49.1% and quality of life (QOL) was considered "much better" in 35.5%. However, 74.0% reported at least one adverse event (AE). In this retrospective study, IN ketamine can serve as an acute treatment for rCM by reducing headache intensity and improving QOL with relatively tolerable AEs. Most patients found IN ketamine effective and continued to use it despite these AEs. The study is limited by its single-center design and selection/recall biases. Well-designed prospective placebo-controlled trials are necessary to demonstrate the efficacy and safety of IN ketamine in patients with migraine.

Competing Interest Statement

Within the past 24 months, Dr. Yuan has received funding from NIH (R44NS115460), institutional support for serving as an investigator from Teva and Abbvie, and royalties from Cambridge University Press and MedLink. Dr. Natekar and Dr. Park have no conflict of interest. Dr. Lauritsen has received consulting fees from Impel. Dr. Viscusi has received consultation fees from Heron, Innocoll, Esteve, and Salix. Dr. Marmura has received compensation for consultation from Alder/Lumbeck, Axsome, Supernus, Theranica, Upsher-Smith, and Satsuma. He has participated in speaker bureaus for Eli Lilly, and Amgen/Novartis. He has received institutional support for serving as principal investigator from Teva, GammaCore, and Allergan/AbbVie. He has received payments for authorship or royalties from Demos Medical, Cambridge University Press, and MedLink.

Funding Statement

Miles for migraine, patient philanthropy

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Thomas Jefferson University IRB.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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