Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department

• This is prospective, randomized, controlled research to compare the efficacy of these two drugs in emergancy department.
• The clinical trial was conducted in the ED of Pamukkale University Medical Faculty Hospital.
• Study personnel (emergency physicians and nurses) were trained before the study.
• When oral drugs (paracetamol, zolmitriptan was being recommended, an eligibility checklist was completed by the attending physician.
• If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial headache pain score ratings with VAS and NRS were recorded.
• The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
• All patients eligible for the study were randomized to one of two groups:
• First Group: paracetamol 1000 mg was given oral to 100 patients,
• Second Group: Zolmitriptan 2,5 mg was given oral to 100 patients which determined to be applied as a group.
• Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations.
• The allocation list was kept by the emergency nurse. Patients received the paracetamol, zolmitriptan medication schemes according to their random allocations.
• After enrollment and recording of baseline information, the next numbered study drug was obtained, and administered as oral.
• Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
• One researcher blinded to patient allocation observed the whole procedure and recorded the Headache scores.
• Headache scores were recorded at 0, 15, 30, and 60 min on a VAS of 1 to 100 mm and NRS of 1 to 10. Patients with nausea are treated with 15 minutes of 10 mg metoclorpramide slow infusion in 150 cc saline solution.
• Rescue medication (1 mcg/kg fentanyl ) was given İntravenöz to patients if pain VAS scores ≥ 50 mm in 60 minutes after study drug administration.
• All other medications required during the study also were recorded.
• During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.

Inclusion criteria

• Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
• Had acute migraine attack without aura
• VAS (visual analog scale) score >50 mm , NRS (Numeric Rating Scale) score >5
• Patients whose written consent is obtained by agreeing to participate in the study

Exclusion criteria

• Those who refuse to participate in the work
• Patients younger than 18 years or older than 65 years
• Those who use ergotamine derivative drugs in the last 24 hours
• Have received analgesics in the last 6 hours
• Patients with severe liver, kidney, lung and heart failure
• To have active peptic ulcer bleeding or perforation
• Have a history of upper gastrointestinal disease
• To be Pregnancy and breast-feeding
• Patients of childbearing age who are not using a birth control method.
• Allergy to medicines used in work
• Hemodynamically unstable patients
• Patients with renal transplantation
• Blood pressure uncontrolled hypertension patients
• Patients with cerebrovascular disease history
• Patients with ischemic heart disease or coronary spasm / printzmetal angina
• Patients with arrhythmia accompanying Wolff-Parkinson-White syndrome or accessory conduits in the heart
• Patients with Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency
• Those with other systemic diseases,
• Patients with a Visual Analogue Scale (VAS) pain score less than 50 mm
• Illiterates and patients with vision problems