Randomised trial of IV metoclopramide vs IV ketorolac in treatment of acute primary headaches
Introduction
Primary headache is the most common cause of emergency department (ED) visits [1,2]. The two most common forms of headaches seen in EDs are migraine and tension-type headaches, which account for 90% of all primary headaches [3,4]. A global burden of disease study showed that headache disorders, particularly migraine, are major causes of disability around the world [5]. Several parenteral medications such as antiemetics, nonsteroidal anti-inflammatory drugs (NSAIDs), antipsychotics, opioids, etc., are used to treat primary headaches. However, the comparison of the guidelines showed that a consensus on the most effective treatment for acute primary headaches has not yet been reached, leading to considerable differences in practice [6,7]. Experience with specific medications, concern about the efficacy and adverse effects, and response to a patient request are the likely reasons for this variation in ED practice [8].
There is increasing evidence demonstrating the efficacy of antidopaminergic, particularly metoclopramide, as one of the main choice of treatment for acute migraine [[9], [10], [11], [12], [13]]. Besides, metoclopramide's low cost, well tolerability, and wide use for the management of nausea make it a favourable choice for emergency physicians [12].
In contrast to migraine, metoclopramide has limited and varying evidence to support its use in treating tension-type headache. For example, Friedman et al. demonstrated that 20 mg IV metoclopramide plus IV diphenhydramine offered more pain relief than 30 mg IV ketorolac for patients with tension-type headache or with non-migraine, non-cluster recurrent headache [14]. However, in Faridaalaee and his colleagues' study, metoclopramide 10 mg IV was found to be less effective than 1 g IV acetaminophen in treatment of patients with primary headaches [15]. Metoclopramide and ketorolac are currently evidence-based acute primary headache therapies widely used in the ED setting [16]. However, their comparative efficacy has not been well investigated. Therefore, the aim of this study was to compare the efficacy of IV metoclopramide with IV ketorolac in order to help emergency physicians decide which of them is superior in treating patients with acute primary headaches.
Section snippets
Study design and setting
This study was a randomised, double-blind clinical trial comparing the analgesic effect of IV metoclopramide (10 mg) and ketorolac (30 mg) in the treatment of patients presenting to ED of Golestan Hospital, Ahvaz, Iran, with acute primary headaches. The Ahvaz Jundishapur University of Medical Science ethics committee approved our protocol, and the trial was registered in the Iranian Registry of Clinical Trials with IRCT Number: IRCT20151103024853N4.
Subjects
Adult patients between 18 and 65 referred to
Results
Between August 2020 to March 2021, 753 patients with acute headache screened at ED of Golestan Hospital. From them, 645 patients met the exclusion criteria, and finally, 108 patients were eligible to accomplish the study and were equally divided into two groups of 10 mg IV metoclopramide and 30 mg IV ketorolac (Fig. 1).
Table 1 displays baseline demographic characteristics of subjects. The mean ± SD of age was 34 ± 8.54 years, and 57.4% of patients were female. In both metoclopramide and
Discussion
The results of this study showed no statistically significant difference between IV metoclopramide and IV ketorolac in pain intensity change 15, 30, or 60 min after administration. The anti-migraine efficacy of metoclopramide has been well-documented in several high-quality clinical trials. For instance, Friedman et al. compared IV metoclopramide with IV ketorolac in patients with acute migraine found that metoclopramide is superior on several endpoints [11]. In another study, Friedman et al.
Conclusion
In this ED-based, randomised, double-blind, comparative efficacy study of acute primary-headache treatment, either 10 mg IV metoclopramide or 30 mg IV ketorolac is an effective therapy, and we failed to reject the null hypothesis that there would be no difference in pain outcomes between the two drugs.
Declarations of interest
None.
Acknowledgements
This study was funded by Ahvaz Jundishapur University of Medical Sciences and granted for the PharmD thesis of Kasra Morad Soltani with approved research project ID PAIN-9711. All authors would like to express their gratitude to all patients and ED staff of Golestan Hospital.
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