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Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252521
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Umut Gulacti, Adiyaman University Research Hospital

Brief Summary:
Acute headache is one of the most common reasons for presentation to the emergency department (ED), accounting for 2-3% of all emergency visits. Migraine is a disorder of the central nervous system characterized by a moderate or severe headache, which is generally associated with nausea and/or sensitivity to light and sound, interfering with daily activities.

Condition or disease Intervention/treatment Phase
Migraine Drug: metoclopramide Drug: dexketoprofen trometamol Drug: metoclopramide+dexketoprofen trometamol Not Applicable

Detailed Description:

Study objective: The objective of this study is to determine the analgesic efficacy and safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to the emergency department (ED).

Methods of Measurements:

This single-center, randomized, double-blind study will be conducted in a tertiary care ED. Eligible patients who met the migraine criteria of the International Headache Society will be randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen trometamol, or 50 mg dexketoprofen trometamol + 10 mg metoclopramide.

Subjects reported pain intensity on both a 100-mm visual analogue scale (VAS) (limited by 'no pain' and 'the worst pain') will be used for pain measurement at baseline, after 15 and 30 min. The primary outcome measure is the changes in the VAS scores at the 15th and 30th minutes of treatment. The secondary outcome measures are the presence of adverse effects and the requirement of rescue medicine.

Primary Data Analysis:

The study was planned as a superiority trial. The difference in the VAS values between the groups was assumed to detect 21.4 mm and the standard deviation (SD) value as 2.8 mm, and thus the minimum required the number of patients for each group was calculated as 27 at the alpha-critical value of 0.05 and power of 80%. All the analyses were implemented according to the intention to treat analysis. Differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Acute Migraine Attack in the Emergency Department: a Randomized Double-blind Controlled Trial
Actual Study Start Date : July 3, 2019
Actual Primary Completion Date : January 3, 2020
Actual Study Completion Date : January 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: metoclopramide+ dexketoprofen trometamol
10 mg metoclopramide+ 50 mg dexketoprofen trometamol
Drug: metoclopramide+dexketoprofen trometamol
10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution
Other Name: Metpamid+Metadem

Experimental: metoclopramide
10 mg metoclopramide
Drug: metoclopramide
10 mg Metpamid in 100 ml normal saline solution
Other Name: Metpamid (metoclopramide)

Experimental: dexketoprofen trometamol
50 mg dexketoprofen trometamol
Drug: dexketoprofen trometamol
50 mg dexketoprofen trometamol in 100 ml normal saline solution
Other Name: Metadem (dexketoprofen trometamol)




Primary Outcome Measures :
  1. Change of the intensity of pain [ Time Frame: 15 minutes and 30 minutes after the study drug administered ]
    Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 15th and 30th minutes later after the study drug administered


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 30 minutes after ]
    30 minutes after the study drug administered

  2. need to rescue medication [ Time Frame: 30 minutes after ]
    30 minutes after the study drug administered



Information from the National Library of Medicine

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

Inclusion Criteria:

-Patients aged 18 and over with acute headache who met the diagnostic criteria of the International Headache Association (9) for the diagnosis of migraine

Exclusion Criteria:

  • Patients who refused to participate in the study
  • Patients that took any analgesic medication within six hours before presentation to ED Patients with any additional organic pathology (e.g., hypertension, hypoglycemia, chronic kidney failure, and intracranial masses) pregnant women hemodynamically unstable patients patients with an allergy to the drugs used in the study

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): NCT04252521


Locations
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Turkey
Adiyaman University Research Hospital
Adıyaman, Central, Turkey, 02000
Sponsors and Collaborators
Adiyaman University Research Hospital
Investigators
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Principal Investigator: Umut Gülaçtı Adiyaman University of Medical Faculty
Publications:
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Responsible Party: Umut Gulacti, Clinical Associate Professor, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier: NCT04252521    
Other Study ID Numbers: 66175679-514.04.01
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexketoprofen trometamol
Ketoprofen
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors