Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack
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|ClinicalTrials.gov Identifier: NCT01730326|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : November 21, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Migraine||Drug: Paracetamol Drug: Dexketoprofen||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Comparison of the Effectiveness of Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack in Emergency Service|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||November 2012|
Paracetamol which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.
Other Name: perfalgan 10 mg/ml
Active Comparator: Dexketoprofen
Dexketoprofen which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.
Other Name: arveles 50 mg/2 ml
- Reduction in visual analogue scale and Numeric Rating Scale [ Time Frame: 15 minutes interval ]The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.
- Adverse events [ Time Frame: 30th minutes after ]30th minutes after the study drug administered
- Reduction in verbal rating scale [ Time Frame: 15 minutes interval ]The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730326
|Pamukkale University Hospital, Emergency Department|
|Denizli, Turkey, 20020|
|Study Director:||Ibrahim Turkcuer, assoc. prof.||Pamukkale University|