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

May 8, 2017 updated by: Ibrahim Turkcuer, Pamukkale University

Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine Headache in Emergency Department: Randomize Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 20070
        • Pamukkale University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Zomig

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change from baseline in migraine headache VAS score at 60 minutes
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)
Change from baseline in migraine headache NRS score at 60 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cuneyt Arikan, MD, Pamukkale University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015TPF039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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