Abstract
Objective
The aim of this randomized controlled study was to compare the efficacy and safety of intravenous (IV) ibuprofen with IV dexketoprofen trometamol in patients with migraine attack-related headaches and receiving IV metoclopramide as part of their standard care.
Methods
This double-blinded and randomized controlled study was conducted among patients with acute migraine-related headaches admitted to the emergency department (ED). Eligible patients were randomly assigned in a 1:1 ratio to receive ibuprofen or dexketoprofen trometamol. In addition, all participants received 10 mg of IV metoclopramide. All patients’ headache scores were measured with a visual analog scale (VAS); 0 points was considered no pain, while 100 points were considered worst pain. The primary outcome was defined as the absolute change in the headache scores between the groups at 0 and 60 min.
Results
A total of 160 patients were randomized into two groups with similar baseline migraine characteristics and VAS scores. In each group, the baseline VAS scores significantly decreased statistically over time. However, when the decreasing trends of VAS values were compared according to the treatment groups, a statistically significant difference was found in the VAS values at 30 min, but no difference was found for the 60 min VAS values. There was no statistically significant difference in the need for rescue treatment and side effects between the two groups.
Conclusion
Intravenous ibuprofen and dexketoprofen trometamol treatments are equal to each other in terms of efficacy, side effects, and need for rescue treatment in the management of acute migraine-related headaches.
Zusammenfassung
Ziel
Ziel dieser randomisierten, kontrollierten Studie war der Vergleich der Wirksamkeit und Sicherheit von Ibuprofen i.v. mit der von Dexketoprofen-Trometamol i.v. bei Patienten, die Kopfschmerzen im Zusammenhang mit Migräneattacken aufwiesen und Metoclopramid i.v. als Teil ihrer Standardbehandlung erhielten.
Methoden
Diese doppelblinde, randomisierte, kontrollierte Studie wurde bei Patienten mit akuten migränebedingten Kopfschmerzen durchgeführt, die in die Notaufnahme eingeliefert wurden. Geeignete Patienten wurden nach dem Zufallsprinzip im Verhältnis 1:1 einer Behandlung mit Ibuprofen oder Dexketoprofen-Trometamol zugeteilt. Zusätzlich erhielten alle Teilnehmer 10 mg Metoclopramid i.v. Die Kopfschmerzwerte aller Patienten wurden mit einer visuellen Analogskala (VAS) gemessen; 0 Punkte galten als kein Schmerz, 100 Punkte als schlimmster Schmerz. Als primärer Endpunkt wurde die absolute Änderung der Kopfschmerzwerte zwischen den Gruppen nach 0 und 60 min definiert.
Ergebnisse
Insgesamt 160 Patienten wurden in zwei Gruppen mit ähnlichen Migränemerkmalen und VAS-Scores zu Studienbeginn randomisiert. In jeder Gruppe nahmen die Ausgangs-VAS-Scores im Laufe der Zeit statistisch signifikant ab. Bei Vergleich der abnehmenden Trends der VAS-Werte gemäß den Behandlungsgruppen wurde jedoch ein statistisch signifikanter Unterschied in den VAS-Werten nach 30 min, aber kein Unterschied in den VAS-Werten nach 60 min gefunden. Es gab keinen statistisch signifikanten Unterschied in der Notwendigkeit einer Notfalltherapie und in den Nebenwirkungen zwischen den beiden Gruppen.
Fazit
Intravenöse Behandlungen mit Ibuprofen und Dexketoprofen-Trometamol sind in Bezug auf Wirksamkeit, Nebenwirkungen und Notwendigkeit einer Notfalltherapie bei der Behandlung akuter migränebedingter Kopfschmerzen gleichwertig.
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S. Şafak, Ş.K. Çorbacioğlu, O. Korucu, E. Emektar and Y. Çevik declare that there is no conflict of interest.
The local ethical committee and ethics committee of Turkish Medicines and Medical Devices Agency approved this study (Kecioren Training and Research Hospital, local ethical committee; approval number 66175679-514.04.01‑E.170568). Informed consent: The patient informed consent was signed by all participants.
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Şafak, S., Çorbacioğlu, Ş.K., Korucu, O. et al. Comparison of ibuprofen and dexketoprofen in the management of migraine-related headache in the emergency department. Notfall Rettungsmed 25 (Suppl 2), 31–37 (2022). https://doi.org/10.1007/s10049-022-01105-w
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DOI: https://doi.org/10.1007/s10049-022-01105-w
Keywords
- Ibuprofen
- Migraine without aura
- Nonsteroidal anti-inflammatory drugs
- Emergency department
- Metoclopramide