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

Primary Purpose

Acute Migraine Headache

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
Zolmitriptan
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Migraine Headache focused on measuring Migraine, Paracetamol, Zolmitriptan, Emergency services

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Paracetamol

Zolmitriptan

Arm Description

1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients

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

Outcomes

Primary Outcome Measures

Decrement of the pain on VAS
1. Compare decrease of migraine headache VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)
Decrement of the pain on NRS
1. Compare decrease of migraine headache NRS (Numeric Rating Scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)

Secondary Outcome Measures

Full Information

First Posted
April 21, 2017
Last Updated
May 8, 2017
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT03145467
Brief Title
Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department
Official Title
Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine Headache in Emergency Department: Randomize Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine Headache
Keywords
Migraine, Paracetamol, Zolmitriptan, Emergency services

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients
Arm Title
Zolmitriptan
Arm Type
Experimental
Arm Description
Second Group: Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Parol
Intervention Description
1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients
Intervention Type
Drug
Intervention Name(s)
Zolmitriptan
Other Intervention Name(s)
Zomig
Intervention Description
Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients
Primary Outcome Measure Information:
Title
Decrement of the pain on VAS
Description
1. Compare decrease of migraine headache VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)
Time Frame
Change from baseline in migraine headache VAS score at 60 minutes
Title
Decrement of the pain on NRS
Description
1. Compare decrease of migraine headache NRS (Numeric Rating Scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)
Time Frame
Change from baseline in migraine headache NRS score at 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cuneyt Arikan, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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