Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack
Condition: Acute Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with acute migraine attack make up the majority of patients consulting the emergency
      services due to headache. The aim of treatment in the emergency service is to achieve a
      minimum level of undesirable side effects and to quickly relieve the pain which will not
      repeat after discharge from the emergency service. Ideal drug treatment contraindication
      should be at a minimum level and not trigger migraine. Paracetamol and Nonsteroidal
      anti-inflammatory drugs are often used in the treatment of migraine headache.

      Although narcotic analgesics provide effective and rapid analgesia, they have such side
      effects as hypotension, nausea and vomiting, drowsiness. In recent years, with the production
      of parenteral forms of non-steroidal anti-inflammatory painkillers, the analgesic efficacy of
      these drugs has been one of the topics of interest to researchers. Especially intravenous
      form of paracetamol is new yet compared to other Nonsteroidal anti-inflammatory drugs, and it
      is a drug with a wide safety margin and less incidence of side effects. The effectiveness of
      the Intravenous form of paracetamol and whether it can be an alternative to other analgesics
      is one of the major research topics today, and more study is needed on this subject.

      Both drugs are often used in emergency services to treat headache caused by acute migraine
      attack. Our aim is to compare the effectiveness of intravenous dexketoprofen with paracetamol
      in the treatment of the headache caused by acute migraine attack.
    

Detailed description: 
      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;

        1. group: Dexketoprofen Trometamol (50 mg)

        2. 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.
    

Intervention name(s): Paracetamol; Dexketoprofen
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg; 50 mg
Other intervention name(s): perfalgan 10 mg/ml; arveles 50 mg/2 ml
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Headache; paracetamol; dexketoprofen; emergency department