Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department
Condition: Acute Migraine Headache
MeSH terms: Migraine Disorders; Emergencies; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Migraine is a chronic and sometimes progressive disorder, characterized by headache,
      recurrent episodes, and other associated symptoms. Migraine is the most common cause of
      headache among patients who applied to emergency services.

      The purpose of the investigators is to compare the efficacy of oral paracetamol and
      zolmitriptan in the treatment of acute migraine headache in an emergency department.
    

Detailed description: 
      -  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.
    

Intervention name(s): Paracetamol; Zolmitriptan
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients; Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients
Other intervention name(s): Parol; Zomig
Intervention MeSH terms: Acetaminophen; Zolmitriptan
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Migraine; Paracetamol; Zolmitriptan; Emergency services