Effectiveness of intravenous dexamethasone, metoclopramide, ketorolac, and chlorpromazine for pain relief and prevention of recurrence in the migraine headache: a prospective double- blind randomized clinical trial

DOI: https://doi.org/10.1007/s10072-019-03766-x

Abstract-Summary Dexamethasone, metoclopramide, ketorolac, and chlorpromazine have been used for the treatment of migraine headache.

Subjects were randomized to four groups; each received one of the following drugs intravenously: dexamethasone 8  mg, ketorolac 30  mg, metoclopramide 10 mg, and chlorpromazine 25 mg.

No significant difference was found in the severity of symptoms between the

four study groups before treatment, 1 h, and 24 h after treatment.

The effect of all mentioned drugs on acute migraine headache was statistically

significant at 1 and 24 h post-treatment compared to baseline.

There was a trend toward higher effectiveness of dexamethasone in prevention of

recurrence (P = 0.05).

The present clinical trial shows the effectiveness of dexamethasone in prevention

of recurrence and low frequency of treatment side effects.

Extended: No significant difference was found in sex ratio between two groups. No significant difference was found in the frequency of aura between patients

treated with any of mentioned drugs at baseline, 1 h, and 24 h after treatment.

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There was a trend toward lower rate of recurrence in the dexamethasone-treated patients and higher rate of recurrence in the metoclopramide-treated patients (P = 0.05).

Future comprehensive studies are needed to evaluate all of these parameters.

Introduction Headache or migraine headache has comprised approximately 5% of referrals to emergency departments [141].

The latter is defined as an idiopathic, recurrent headache disease demonstrated with episodes of neurological symptoms clearly localizable to the cerebral cortex or brain stem, typically emerging progressively over 5–20  min and continuing less than 60 min.

Dopamine-receptor antagonists (such as chlorpromazine and metoclopramide), non-steroidal anti-inflammatory drugs (such as ketorolac), and corticosteroids (such as dexamethasone) are among the drugs being used in management of acute migraine in adults in the emergency department situations [142].

In the present clinical trial, we aimed at comparing the efficacy of these treat- ments in pain relief and prevention of migraine recurrence as well as their side effects in patients referred to the emergency ward.

Material and Methods Patients with any of the following conditions were excluded from the study: hyper- tension, renal failure, any cardiac or respiratory disease, hepatic failure, epilepsy, malignancy, acute inflammatory disease or infection, peptic ulcer, pregnancy, breastfeeding, neurological deficit, history of immune-suppressive drugs, ergota- mine use in the previous 8 h, and anxiolytic use in the previous 4 h. The appropriate sample size for the study was calculated using the following equation where p1 and p0 were the efficacy of chlorpromazine and metoclopramide in reducing migraine pain, respectively [143, 144]: A total of 128 (4 × 32) patients were randomly divided into four groups; each received one of the following drugs intravenously: dexa- methasone 8 mg, ketorolac 30 mg, metoclopramide 10  mg, and chlorproma- zine 25 mg.

Variables evaluated in the study were headache intensity according to VAS crite- ria (before treatment, 1 h and 24 h after treatment), family history of migraine, age, and sex.

Results Mann-Whitney U test showed no significant difference in mean age of two groups (P = 0.53).

A total of 53.1% of patients had family history of migraine with no significant

difference between two groups as evaluated by logistic regression model.

No significant difference was found in the frequency of aura between patients

treated with any of mentioned drugs at baseline, 1 h, and 24 h after treatment.

Chi-square test showed no significant difference between the four groups in

response to treatment (P = 0.07).

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Chi-square test showed significant differences between the four groups in fre- quencies of minor side effects in a way that dexamethasone and chlorpromazine had the lower and higher side effects, respectively (X2 = 22.55, Df = 3, p < 0.001).

Discussion Previous studies comparing the effects of sodium valproate and dexamethasone on migraine headache reported no significant difference between these drugs in control of headache especially in patients without aura [145, 146].

A previous prospective randomized double-blind trial in patients with acute migraine has compared the effects of chlorpromazine and metoclopramide and reported effectiveness of both drugs in the management of acute migraine headache with similar minor side effect profiles [147].

The results of our study regarding the lower rate of recurrence in the dexametha- sone treated-patients are in line with the results of a meta-analysis which evaluated the efficacy of parenteral corticosteroids for the relief of acute severe migraine headache and avoidance of recurrence.

The lower recurrence rate and side effects of dexamethasone compared with the other three drugs along with its effectiveness in pain relief imply its superiority in management of acute migraine in emergency departments.

Acknowledgement A machine generated summary based on the work of Khazaei, Mojtaba; Hosseini Nejad Mir, Nahid; Yadranji Aghdam, Fateme; Taheri, Mohammad; Ghafouri-Fard, Soudeh. 2019 in Neurological Sciences.

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European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention