Comparing the analgesic effects of intravenous metoclopramide and acetaminophen with intravenous metoclopramide and placebo on acute migraine headache.
Design
Clinical trial with a control group, with parallel groups, triple blinded, randomized, phase 2-3 on 88 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
This study will be conducted in the emergency department of Besath Hospital in Hamadan on patients referred for acute migraine headaches. Patients will be assigned to two intervention and control groups using the sealed envelope method. The intervention group will receive intravenous metoclopramide and acetaminophen infusion and the control group will receive metoclopramide infusion and placebo . The study is conducted in a triple blinded method. Medicines will be prepared by the ward nurse in the same form, and the patient, physician and data analyst will be unaware of the treatment groups.
Participants/Inclusion and exclusion criteria
The participants will be patients aged 18 to 60 years who referred to the emergency department of the hospital with acute migraine headache symptoms. The criteria for not entering the study will include allergy to metoclopramide or acetaminophen, a history of any type of disease that the patient has a contraindication for metoclopramide or acetaminophen, and suspicion of other causes other than migraine for headache.
Intervention groups
One group will first receive 2 cc (equivalent to 10 mg) of metoclopramide intraserum. Then, one gram of intravenous acetaminophen (equivalent to 7 cc) along with 100 cc of normal saline will be infused over 10 minutes.
The second group will first receive 2 cc of metoclopramide, then they will receive 7 cc of normal saline infused with 100 cc of normal saline over 10 minutes.
Main outcome variables
The severity of migraine headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N37
Registration date:2024-04-19, 1403/01/31
Registration timing:prospective
Last update:2024-04-19, 1403/01/31
Update count:0
Registration date
2024-04-19, 1403/01/31
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of metoclopramide and acetaminophen with metoclopramide and placebo in the management of acute migraine headache
Public title
Investigating the anti-headache effects of metoclopramide and acetaminophen in comparison with metoclopramide and placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of migraine criteria according to the classification of the International Headache Society
Headache pattern consistent with migraine and previous attack
Exclusion criteria:
History of allergy to metoclopramide or acetaminophen
History of liver, renal and heart failure, malignancy
Pregnancy and breastfeeding
History of gastrointestinal obstruction or gastrointestinal bleeding or clinical suspicion of either
Trauma, seizure or abnormal neurological examination
Smoking or drug use
High systolic and diastolic blood pressure
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
We made 88 cards and write letter I (Intervention) on 44 and on the other 44 letter C (control). Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter (A or B) patients will be assigned to Intervention or Control group
Blinding (investigator's opinion)
Triple blinded
Blinding description
Medicines will be prepared in the same form (intravenous infusion during 10 minutes). Patients, physician and the statistical analyst will not know about the codes used for the drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Science
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2023-11-22, 1402/09/01
Ethics committee reference number
IR.UMSHA.REC.1402.546
Health conditions studied
1
Description of health condition studied
Acute migraine headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Headache Severity
Timepoint
Before treatment, 15 minutes and 30 minutes after treatment
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Need for additional analgesic
Timepoint
60 minutes after treatment onset
Method of measurement
Extracting on patient's medical record
2
Description
Complications, nausea, vomiting, blurred vision, drowsiness and restlessness
Timepoint
Within an hour after treatment
Method of measurement
by asking the patients
Intervention groups
1
Description
Intervention group: First, they will receive 2 cc (equivalent to 10 mg) of metoclopramide intraserum. Then, one gram of intravenous acetaminophen (equivalent to 7 cc) along with 100 cc of normal saline will be infused over 10 minutes.
Category
Treatment - Drugs
2
Description
Control group: First, they will receive 2 cc (equivalent to 10 mg) of metoclopramide intraserum, then they will receive 7 cc of normal saline as a placebo infused with 100 cc of normal saline over 10 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Omid Shokohi
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6515974544
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Vice chancellor for Research and technology of Hamadan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Omid Shokohi
Position
Emergency Medicine MD
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Beheshti Blv
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
Email
Omid.shokoohi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Omid Shokohi
Position
Emergency Medicine MD
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Beheshti Blv
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
Email
Omid.shokoohi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From the Sep 2024
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
For treatment of patients and develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document