Protocol summary

Study aim
Comparison of the efficacy of intranasal ketamine with intravenous ketorolac in reducing non-traumatic acute headache
Design
This study is a randomized controlled clinical trial study and is a double blind study
Settings and conduct
After approval the study at Kermanshah University of Medical Sciences, it started at Taleghani Hospital Emergency Department.Randomization was performed in this study by simple random method. After identifying eligible patients, they will be assigned a random three-digit proprietary code. The last digit on the right determines the patient group. If the figure is 0, 1, 2, 3, 4, it will be placed in the intervention group (Kotorlac) and if the figure is 5, 6, 7, 8, 9 it will be placed in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria consist of :All patients with complaints of non-traumatic acute headache patients with aged of 18 to 50 years old Patients with a variety of headaches including tension and cluster migraine headaches Exclusion criteria consist of: Subjects who have contraindications to the use of ketorolac and vitamin drugs Patients with focal neurological disorder Pregnant and weaning women Patients with headache with impaired consciousness level Patients with Comorbidity Headaches (Liver and Kidney Failure Immune Deficiency)
Intervention groups
In this study, placebo was used for control group. Normal saline was given as placebo in both intranasal and intranasal forms. Given that ketorlac was used intranasally and ketamine injectable, everyone in the intervention group received intranasal ketorlac and normal saline (as placebo). Patients in control group received intranasal ketamine and normal saline (as placebo).
Main outcome variables
pain score base of visual analog score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180108038276N3
Registration date: 2019-09-29, 1398/07/07
Registration timing: registered_while_recruiting

Last update: 2019-09-29, 1398/07/07
Update count: 0
Registration date
2019-09-29, 1398/07/07
Registrant information
Name
amir noyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 2186
Email address
a.noyani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study on the Effect of Intranasal Ketamine with Intravenous Ketorolac on Reduction of Non-Traumatic Acute headache
Public title
Comparison of intranasal ketamine and intravenous ketorolac in reducing non-traumatic acute headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with complaints of non-traumatic acute headache patients with aged of 18 to 50 years old Patients with a variety of headaches including tension and cluster migraine headaches
Exclusion criteria:
Subjects who have contraindications to the use of ketorolac and vitamin drugs Patients with focal neurological disorder Pregnant and weaning women Patients with headache with impaired consciousness level Patients with Comorbidity Headaches (Liver and Kidney Failure and Immune Deficiency)
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by simple random method, after identifying eligible patients, they will be randomly assigned a three-digit proprietary code. The last digit on the right determines the patient group. If the figure is 0, 1, 2, 3, 4, it will be placed in the intervention group (Kotorlac) and if the figure is 5, 6, 7, 8, 9, it will be placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Nurses and people in charge of care are not aware of the allocation of groups. The person evaluating the patients is also not aware of the allocation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Kermanshah University of Medical Science
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.Kermashah,iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.KUMS.REC.1398.068

Health conditions studied

1

Description of health condition studied
Patients with acute non-traumatic headaches
ICD-10 code
G44
ICD-10 code description
Other headache syndromes

Primary outcomes

1

Description
Pain score of patients with acute non-traumatic headache with visual analogue scale
Timepoint
Pain will be measured immediately before drug administration, 30 minutes, 1 minute and 2 hours after drug administration.
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1 was treated with intravenous ketorolac at a dose of 0.5 mg / kg intravenously in a single dose.
Category
Treatment - Drugs

2

Description
Intervention group 2 received intravenous ketamine at a dose of 0.5 mg / kg intravenously.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital Kermanshah
Full name of responsible person
hooman rafiee sarvari
Street address
Taleghani Hospital,Taleghani Street,Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 23 3223 8115
Email
hooman.rafiee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah university of Medical Science, Taleghani Street, Kermanshah,Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 0541
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
hamid reza beyg rezaee
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Taleghani Hospital,Taleghani Street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
0098233221620
Email
hbaigrezaii@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
hooman.rafiee sarvari
Position
Assistance Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Taleghani Hospital, Taleghani Street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
0098233221620
Email
hooman.rafiee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Noyani
Position
Assistance Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Taleghani Hospital, Taleghani Street, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 23 3222 1620
Email
a.noyani@shmu.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data on demographic information and patient pain are distributed as anonymous codes
When the data will become available and for how long
Starting data access is from 2019
To whom data/document is available
Access to data will be free for anyone interested in research
Under which criteria data/document could be used
Granting data for scientific use without fringe is allowed
From where data/document is obtainable
Can contact with a.noyani@shmu.ac.ir email
What processes are involved for a request to access data/document
About a month from the time of the first call through the email
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