Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack

Materials and Methods of Research:

Among the patients consulting the emergency service with a complaint of headache, those who meet the criteria of 'International Classification of Headache Disorders criteria for migraine without aura' and agreed to participate in the study will form the study group.

The patients forming the study group will be included in the study after they are evaluated according to the criteria of inclusion or exclusion. Our research is an equivalence study. Provided that the difference between the groups is 50 %, α: 99 %, and 1-β: 80 %, it has been determined that each group should include at least 94 subjects, and the number of voluntary subjects has been determined as 200, each group containing 100 subjects.

First of all, in the measurement of the frequency of headaches, the standard 11-point Numeric Rating Scale (NRS), whose reliability is proven, and 100-mm visual analog scale (VAS) will be used. For NRS, patients will be asked to score their pain on a scale ranging from 0 to 10, scoring 0 (zero) in the absence of pain, and 10 in the case of most severe pain; whereas, for VAS, they will be asked to score their pain on a scale ranging from 0 to 100, scoring 0 in the absence of pain, and 100 in the case of most severe pain. Verbal rating scale (VRS) with 4 standard points will be used as another measurement tool. In this measurement, patients will be asked to express their pain as severe, moderate, mild and no pain.

The patients will be divided to two groups.

Groups and drug doses to be given;

• group: Dexketoprofen Trometamol (50 mg)
• group: Paracetamol (1000 mg)

The drug which will be given after randomization will be diluted in 150 ml serum physiologic and will be given as intravenous rapid infusion.

The pains of the patients will be assessed in 0., 15. and 30. minutes by NRS, VAS and VRS, and they will be monitored for vital signs and possible side effects.

In 30. minute, the study will be ended, and If the pain continues, fentanyl 1 mcg / kg will be given.

When a patient eligible for the study consults, after obtaining the patient's written consent, the patient will be assigned to one of the study groups based on the next study number. Randomization of study numbers will be prepared by someone other than a person working in the emergency service with the help of a computer, and until the completion of the study, which number is assigned to which drug will be known only by that person. One of the nurses working in the emergency department will be responsible for preparing the study drug, while the other nurse blindly will be responsible for giving the study drug. The numbers belong to the previously enumerated study groups will be stored in envelopes which do not show the inside (allocation concealment), and the study drug will be prepared after the next envelope is opened by the study nurse. Patients eligible for the study will be taken to the unit called 'observation with monitor' in the emergency department, monitored and IV vascular access will be established. The study drugs will be prepared by the emergency nurse responsible for the study and will be given by the other nurse. Medicines prepared for each group are transparent and same.

• Inclusion Criteria:

a. Patients who are 18 years of age and older, and who agreed to participate in the study will be included in the study.

• Exclusion Criteria:

• Patients having received analgesic in the last six hours,
• pregnant women,
• women of childbearing potential and not using birth control,
• those who do not agree to participate in the study,
• those under age of 18, those who have signs of peritoneal irritation,
• those who are allergic to drugs used in the study,
• hemodynamically unstable patients,
• patients with renal transplant,
• those who suffer from liver, kidney, cardiac and pulmonary insufficiency and others with systemic diseases,
• patients with vision problems and those who are illiterate will be excluded from the study.