Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-05-23 @ 8:59 AM
Study NCT ID:
NCT03145467
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2017-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department
Sponsor:
Pamukkale University
Organization:
Study Overview
Official Title:
Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine Headache in Emergency Department: Randomize Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: