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

November 15, 2012 updated by: Mustafa Serinken, Pamukkale University

The Comparison of the Effectiveness of Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack in Emergency Service

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20020
        • Pamukkale University Hospital, Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • arveles 50 mg/2 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes interval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 30th minutes after
30th minutes after the study drug administered
30th minutes after

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Study Director: Ibrahim Turkcuer, assoc. prof., Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

November 21, 2012

Last Update Submitted That Met QC Criteria

November 15, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • turkcuer 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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