Evaluating the effectiveness of intravenous Propofol plus paracetamol versus paracetamol alone in benign headaches, a randomized placebo controlled clinical trial.
Evaluating the effect of intravenous propofol and paracetamol on the pain reduction of patients with benign headaches.
Design
A clinical trial with two parallel control and case groups، randomized and double-blind.
Settings and conduct
This study was conducted in the two university-affiliated hospitals in Tehran. Patients aged over 18 years with benign headaches included in the study. The research team comprised of 4 physicians and four nurses. Participants were randomly assigned in two groups, paracetamol plus propofol, and paracetamol placebo. Medications were prepared in the covered vials by a pharmacist. The research team was blinded to the patient's assignment. Vital signs and pain intensity of the patients before and after the intervention were evaluated at 0, 10, 20, 30, 60 minutes using the numerical rating scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged over 18 years with benign headaches.
Exclusion criteria: Pregnancy; Allergy to the medications; chronic liver disease; signs and symptoms of secondary headaches.
Intervention groups
The first group will receive 1gr of intravenous paracetamol in 100 ccs normal saline over 20 minutes and 1mg/kg intravenous propofol.
The second group will receive 1gr of intravenous paracetamol in 100 ccs normal saline over 20 minutes and placebo.
Main outcome variables
Pain intensity using the numeric rating scale; systolic blood pressure; diastolic blood pressure; heart rate; oxygen saturation at 0,10, 20, 30, 60 minutes after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141116019971N4
Registration date:2019-09-02, 1398/06/11
Registration timing:registered_while_recruiting
Last update:2019-09-02, 1398/06/11
Update count:0
Registration date
2019-09-02, 1398/06/11
Registrant information
Name
Ehsan Karimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3600
Email address
e-karimi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-19, 1398/05/28
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of intravenous Propofol plus paracetamol versus paracetamol alone in benign headaches, a randomized placebo controlled clinical trial.
Public title
Propofol plus paracetamol in benign headaches.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and above
Benign headaches
Exclusion criteria:
Suspicious to secondary headaches based on the attending physician's judgment
Abnormal vital signs
Variation in the level of consciousness
Fever
Focal neurologic defficite
Pregnancy
Allergy to the egg yolk, acetaminophen or propofol
Neck stiffness
Hepatic failure an chronic liver disease
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
A pharmacist was providing the medication and placebo in the masked vials. Physicians were not aware of the patient's assignment. The nurse who was injecting the drug was also unaware of patients assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poorsina Avenue, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653861
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
92-04-30-27786-135783
Health conditions studied
1
Description of health condition studied
Headache
ICD-10 code
R51
ICD-10 code description
Headache
Primary outcomes
1
Description
Pain intensity
Timepoint
0,10, 20, 30, 60 minutes
Method of measurement
Numeric rating scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
0,10, 20, 30, 60 minutes
Method of measurement
Blood pressure cuff
2
Description
Heart rate
Timepoint
0,10, 20, 30, 60 minutes
Method of measurement
Cardiac monitoring device
3
Description
Oxygen saturation
Timepoint
0,10, 20, 30, 60 minutes
Method of measurement
Puls oxymeter
Intervention groups
1
Description
Intervention group: receives 1gr of intravenous paracetamol in 100 ccs normal saline over 20 minutes and 1mg/kg intravenous propofol. Medications: 1. Paracetamol: G.E.S. Injection 10 mg/ml,100 ml, Genpharma Co (Spain) 2. Propofol: LIPURO Injection 10mg/ml,50 ml, B.Braun (Germany) 3. Normal saline: SODIUM CHLORIDE 0.9% INF P-BOTTLE, SAMEN Co, 1L
Category
Treatment - Drugs
2
Description
Control group: receives 1gr of intravenous paracetamol in 100 ccs normal saline over 20 minutes and placebo. Medications: 1. Paracetamol: G.E.S. Injection 10 mg/ml,100 ml, Genpharma Co (Spain) 2. Normal saline: SODIUM CHLORIDE 0.9% INF P-BOTTLE, SAMEN Co, 1L 3. Placebo: Normal saline will be used as a placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Compelex
Full name of responsible person
Dr Mojtaba Aghili
Street address
Imam Khomeini Hospital Complex, Keshavarz Boulevard, Dr Gharib street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
aghili220@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Ehsan Karimi
Street address
Sina Hospital, 30th Tir Street, Imam Khomeini Ave
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
drkarimi86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Vice chancellery for research and technology, 6Th Floor, Central office of Tehran University of Medical Sciences, Qods Ave, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Aghili
Position
Assisstant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Dr gharib Avenue, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6690 4848
Fax
Email
aghili220@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Karimialavijeh
Position
Assistant Professor of emergency medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Dr Shariati hospital, North Karegar Ave
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 84901
Fax
Email
drkarimi86@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Karimialavijeh
Position
Assistant Professor of emergency medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Dr Shariati hospital, North Karegar Ave
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 84901
Fax
Email
drkarimi86@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
upon completion of the study, Individual participant data (anonymous) comprising age, gender, pain intensity, and vital signs will be released.
When the data will become available and for how long
Access to the information starts in 2020.
To whom data/document is available
All researchers have the possibility to access the data regardless of the research field.
Under which criteria data/document could be used
There are no specific criteria for data access.
From where data/document is obtainable
To request data access, please contact to Dr Ehsan Karimi.
E-mail: drkarimi86@gmail.com, Phone number: 00989122493628, Address: Dr Shariati hospital,North Karegar ave, .
What processes are involved for a request to access data/document