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Trial record 4 of 264 for:    Migraine AND Acute Migraine

Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department

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ClinicalTrials.gov Identifier: NCT03145467
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Ibrahim Turkcuer, Pamukkale University

Brief Summary:

Migraine is a chronic and sometimes progressive disorder, characterized by headache, recurrent episodes, and other associated symptoms. Migraine is the most common cause of headache among patients who applied to emergency services.

The purpose of the investigators is to compare the efficacy of oral paracetamol and zolmitriptan in the treatment of acute migraine headache in an emergency department.


Condition or disease Intervention/treatment Phase
Acute Migraine Headache Drug: Paracetamol Drug: Zolmitriptan Phase 4

Detailed Description:
  • This is prospective, randomized, controlled research to compare the efficacy of these two drugs in emergancy department.
  • The clinical trial was conducted in the ED of Pamukkale University Medical Faculty Hospital.
  • Study personnel (emergency physicians and nurses) were trained before the study.
  • When oral drugs (paracetamol, zolmitriptan was being recommended, an eligibility checklist was completed by the attending physician.
  • If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial headache pain score ratings with VAS and NRS were recorded.
  • The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
  • All patients eligible for the study were randomized to one of two groups:
  • First Group: paracetamol 1000 mg was given oral to 100 patients,
  • Second Group: Zolmitriptan 2,5 mg was given oral to 100 patients which determined to be applied as a group.
  • Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations.
  • The allocation list was kept by the emergency nurse. Patients received the paracetamol, zolmitriptan medication schemes according to their random allocations.
  • After enrollment and recording of baseline information, the next numbered study drug was obtained, and administered as oral.
  • Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
  • One researcher blinded to patient allocation observed the whole procedure and recorded the Headache scores.
  • Headache scores were recorded at 0, 15, 30, and 60 min on a VAS of 1 to 100 mm and NRS of 1 to 10. Patients with nausea are treated with 15 minutes of 10 mg metoclorpramide slow infusion in 150 cc saline solution.
  • Rescue medication (1 mcg/kg fentanyl ) was given İntravenöz to patients if pain VAS scores ≥ 50 mm in 60 minutes after study drug administration.
  • All other medications required during the study also were recorded.
  • During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine Headache in Emergency Department: Randomize Controlled Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Paracetamol
1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients
Drug: Paracetamol
1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients
Other Name: Parol

Experimental: Zolmitriptan
Second Group: Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients.
Drug: Zolmitriptan
Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients
Other Name: Zomig




Primary Outcome Measures :
  1. Decrement of the pain on VAS [ Time Frame: Change from baseline in migraine headache VAS score at 60 minutes ]
    1. Compare decrease of migraine headache VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)

  2. Decrement of the pain on NRS [ Time Frame: Change from baseline in migraine headache NRS score at 60 minutes ]
    1. Compare decrease of migraine headache NRS (Numeric Rating Scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
  • Had acute migraine attack without aura
  • VAS (visual analog scale) score >50 mm , NRS (Numeric Rating Scale) score >5
  • Patients whose written consent is obtained by agreeing to participate in the study

Exclusion Criteria:

  • Those who refuse to participate in the work
  • Patients younger than 18 years or older than 65 years
  • Those who use ergotamine derivative drugs in the last 24 hours
  • Have received analgesics in the last 6 hours
  • Patients with severe liver, kidney, lung and heart failure
  • To have active peptic ulcer bleeding or perforation
  • Have a history of upper gastrointestinal disease
  • To be Pregnancy and breast-feeding
  • Patients of childbearing age who are not using a birth control method.
  • Allergy to medicines used in work
  • Hemodynamically unstable patients
  • Patients with renal transplantation
  • Blood pressure uncontrolled hypertension patients
  • Patients with cerebrovascular disease history
  • Patients with ischemic heart disease or coronary spasm / printzmetal angina
  • Patients with arrhythmia accompanying Wolff-Parkinson-White syndrome or accessory conduits in the heart
  • Patients with Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency
  • Those with other systemic diseases,
  • Patients with a Visual Analogue Scale (VAS) pain score less than 50 mm
  • Illiterates and patients with vision problems

Information from the National Library of Medicine

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): NCT03145467


Locations
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Turkey
Pamukkale University
Denizli, Turkey, 20070
Sponsors and Collaborators
Pamukkale University
Investigators
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Principal Investigator: Cuneyt Arikan, MD Pamukkale University

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Responsible Party: Ibrahim Turkcuer, professor, Pamukkale University
ClinicalTrials.gov Identifier: NCT03145467     History of Changes
Other Study ID Numbers: 2015TPF039
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ibrahim Turkcuer, Pamukkale University:
Migraine
Paracetamol
Zolmitriptan
Emergency services

Additional relevant MeSH terms:
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Migraine Disorders
Emergencies
Headache
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Zolmitriptan
Oxazolidinones
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors