This open-label pilot study (n=20) investigated the safety and efficacy of intranasal ketamine for treating a single cluster headache (CH) attack. While the primary endpoint of a 50% reduction in pain intensity within 15 minutes was not met, at 30 minutes post-treatment, pain intensity was significantly reduced by 59% on an 11-point scale, with no serious adverse events reported.
Abstract of Intranasal ketamine for acute cluster headache attacks—Results from a proof-of-concept open-label trial
“Objective: To investigate the safety and efficacy of intranasal ketamine for the treatment of a single cluster headache (CH) attack.
Background: Acute treatment options for patients with CH who have an insufficient response to oxygen and triptans are limited. Intranasal ketamine has anecdotally been successful in treating a CH attack.
Methods: We conducted an open-label pilot study enrolling 23 patients with chronic CH (Internation Classification of Headache Disorders, 3rd edition), and of these, 20 patients treated a single CH attack with intranasal ketamine. Under in-hospital observation, patients received 15 mg of intranasal ketamine every 6 min a maximum of five times. The primary endpoint was a 50% reduction in pain intensity within 15 min after initiating treatment.
Results: The primary endpoint was not met; 15 min after the first ketamine administration, the mean reduction in pain intensity was 1.1 (95% confidence interval [CI]: -0.6 to 2.7,p=0.188) on the numeric rating scale (NRS), equivalent to a 15% reduction in pain intensity. However, 30 min after the first application, the pain intensity was reduced by 59% on an 11-point NRS (mean difference: 4.3, 95% CI: 2.4-6.2,p<0.001, N = 16) and 11 out of 16 (69%) scored 4 or below on the NRS. Four patients received rescue medication 15 min after the first ketamine application and were therefore excluded from the analysis at 30 min. Half of the patients preferred ketamine to oxygen and/or sumatriptan injection. No serious adverse events were identified during the trial.
Conclusion: Intranasal ketamine may be an effective acute treatment for CH at 30 min but should be tested in a larger controlled design. Patients and physicians should be conscious of the abuse potential of ketamine.”
Authors: Anja S. Petersen, Adam S. Pedersen, Mads C. J. Barloese, Per Holm, Ole Pedersen, Rigmor H. Jensen & Agneta H. Snoer
Summary of Intranasal ketamine for acute cluster headache attacks—Results from a proof-of-concept open-label trial
Cluster headache is usually treated with subcutaneous or intranasal triptans and inhaled oxygen, but 20% – 30% of patients are not adequately relieved by triptans and oxygen. Several alternative therapies exist, but they are hindered by long-term side effects or abuse potential.
Ketamine has been used as an anesthetic and analgesic for chronic pain since the 1970s, and may be effective in the treatment of an acute CH attack.
Methods
Find this paper
https://doi.org/10.1111/head.14220
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Cite this paper (APA)
Petersen, A. S., Pedersen, A. S., Barloese, M. C., Holm, P., Pedersen, O., Jensen, R. H., & Snoer, A. H. (2022). Intranasal ketamine for acute cluster headache attacks—results from a proof‐of‐concept open‐label trial. Headache: The Journal of Head and Face Pain, 62(1), 26-35.
Study details
Compounds studied
Ketamine
Topics studied
Headache Disorders
Pain
Study characteristics
Original
Open-Label
Participants
23
Humans
Compound Details
The psychedelics given at which dose and how many times
Ketamine 15 mg | 5xLinked Clinical Trial
Proof of concept study for evaluation of the effect of ketamine intranasal spray in treatment of chronic Cluster Headache (CCH)This open-label trial (n=20) conducted in Denmark by CCH Pharmaceuticals, with the protocol code CCH01, aimed to assess the efficacy of ketamine intranasal spray in treating chronic Cluster Headache (CCH)