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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mustafa Serinken, Pamukkale University
ClinicalTrials.gov Identifier:
NCT01730326
First received: November 5, 2012
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Acute Migraine
Drug: Paracetamol
Drug: Dexketoprofen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pamukkale University:

Primary Outcome Measures:
  • Reduction in visual analogue scale and Numeric Rating Scale [ Time Frame: 15 minutes interval ] [ Designated as safety issue: No ]
    The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 30th minutes after ] [ Designated as safety issue: No ]
    30th minutes after the study drug administered


Other Outcome Measures:
  • Reduction in verbal rating scale [ Time Frame: 15 minutes interval ] [ Designated as safety issue: No ]
    The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.


Enrollment: 200
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol
Paracetamol which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.
Drug: Paracetamol
1000 mg
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.
Drug: Dexketoprofen
50 mg
Other Name: arveles 50 mg/2 ml

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. 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.

  2. Exclusion Criteria:

    1. Patients having received analgesic in the last six hours,
    2. pregnant women,
    3. women of childbearing potential and not using birth control,
    4. those who do not agree to participate in the study,
    5. those under age of 18, those who have signs of peritoneal irritation,
    6. those who are allergic to drugs used in the study,
    7. hemodynamically unstable patients,
    8. patients with renal transplant,
    9. those who suffer from liver, kidney, cardiac and pulmonary insufficiency and others with systemic diseases,
    10. patients with vision problems and those who are illiterate will be excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730326

Locations
Turkey
Pamukkale University Hospital, Emergency Department
Denizli, Turkey, 20020
Sponsors and Collaborators
Pamukkale University
Investigators
Study Director: Ibrahim Turkcuer, assoc. prof. Pamukkale University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mustafa Serinken, Pamukkale University denizli / TURKEY, Pamukkale University
ClinicalTrials.gov Identifier: NCT01730326     History of Changes
Other Study ID Numbers: turkcuer 001
Study First Received: November 5, 2012
Last Updated: November 15, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Pamukkale University:
Headache
paracetamol
dexketoprofen
emergency department

Additional relevant MeSH terms:
Headache
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014