Abstract and Introduction
Objective: The objective of this study was to assess the efficacy and safety of a common monotherapy (intravenous [iv] metoclopramide) compared to a combination strategy (adding iv ketorolac to metoclopramide) in children presenting for acute treatment of migraine headache in the emergency department (ED).
Methods: Children aged 5–17 years presenting for acute treatment of migraine headache at two pediatric EDs were enrolled in a double-blind randomized controlled trial. Children were randomly assigned to receive iv metoclopramide 0.2 mg/kg) and placebo or iv metoclopramide (0.2 mg/kg) and ketorolac (0.5 mg/kg). The primary outcome was a mean change in pain from baseline to 120 min via a 100 mm Visual Analog Scale (VAS). Follow-up was conducted 24-h after discharge.
Results: Fifty-three children were randomized and included in the analysis (monotherapy group [metoclopramide + placebo], n = 27; and ketorolac group [metoclopramide + ketorolac], n = 26); mean age was 12.9 ± 2.7 years and baseline pain severity on VAS was 67.3 ± 2.7 mm. The mean change in pain intensity at 120 min was −44 mm (SD: 24; 95% confidence interval [CI]: 32–57) for the monotherapy group and −36 mm (SD: 24; 95% CI: 23–49) for the ketorolac group, with a mean difference between groups of 8 mm (95% CI: −9–25; p = 0.360). Seventeen percent of the children (9/53; 95% CI: 7–27%) were pain-free at discharge. There was no difference in headache recurrence or adverse events between groups.
Conclusions: The approach of combining iv metoclopramide with ketorolac failed to improve pain scores in children presenting for acute treatment of migraine headache in the ED compared to metoclopramide monotherapy. Most patients were discharged with residual pain. Further comparative studies are needed to test alternative ED treatments for migraine in children or adolescents.
When self-administered treatments like oral nonsteroidal anti-inflammatory drugs (NSAIDs) or migraine-specific medications like serotonin receptor agonists fail to provide relief or the pain is particularly severe, patients will often present to emergency departments (ED) for acute treatment of migraine headache. ED-based treatment of migraine headache has significant implications on healthcare resource utilization, as therapy often includes the use of intravenous (iv) therapies, such as metoclopramide, prochlorperazine, or ketorolac.[2,3]
Due to a paucity of research, there is considerable variation in the management of children with migraine headache in the ED. Intravenous ketorolac, alone or in combination with other agents, is one of the most common drugs, being used in close to 40% of ED presentations.[2–4] Nonselective NSAIDs, such as naproxen sodium and ketorolac, have been shown to be effective in the reduction of central sensitization in animal models of migraine and the reduction of migraine pain in adult patients. Most patients present to the ED late during their attack when central sensitization is more likely to have occurred making ketorolac a compelling addition to standard treatments. The objectives of this clinical trial were to evaluate the efficacy and safety of combined iv therapy (metoclopramide and ketorolac) versus iv monotherapy (metoclopramide alone). We hypothesized that combination therapy may be more effective than monotherapy in this population of patients presenting to the ED with a migraine attack.
Headache. 2022;62(6):681-689. © 2022 Blackwell Publishing