Protocol summary

Study aim
Determining and comparing the effect of Ketorolac 30 mg IV and haloperidol 5 mg IV in reducing the severity of headache in patients with the chief complaint of headache at the emergency department of Sina Hospital.
Design
1 ml ampoules of 5 mg of haloperidol and 30 mg of ketorolac will be used. The pharmacist covers the ampoules and puts them in the envelope. Then he picks the envelopes in the order of the random sequence and delivers them to the researcher. Unawareness of patients, health care providers, and outcome reviewers was ensured as to which intervention group they were placed in.
Settings and conduct
Blinding of the patient and the researcher is done in the emergency room of Sinai Hospital
Participants/Inclusion and exclusion criteria
People aged 18 to 55 years who went to the emergency room with the main complaint of headache. Exclusion: Abnormal blood pressure (> 100/200 mmHg) Sudden or rapid onset Fever Acute trauma History of brain mass History of stroke History of abnormal intracranial anatomy QTc > 450 ms on the heart monitor strip Altered mental status Allergy to haloperidol Allergy to ketorolac Airway diseases such as asthma Active peptic ulcer Advanced renal failure Recent major surgery new abnormal findings on neurological examination clinical doubt of the doctor that requires a CT scan of the brain or Lumbar Puncture pregnancy drugs that prolong the QT interval hepatic failure Epilepsy or history of seizures hyperthyroidism parkinsonism Chronic psychiatric disease Concomitant use or within 2 weeks of discontinuing an MAOI Active gastritis or peptic ulcer disease History of upper gastrointestinal bleeding Previous participation in the same study Dissatisfaction
Intervention groups
Two groups with headaches were referred to the emergency room, one group was randomly intravenous ketorolac, and the other group with IV haloperidol.
Main outcome variables
pain reduction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231220060477N1
Registration date: 2024-06-13, 1403/03/24
Registration timing: registered_while_recruiting

Last update: 2024-06-13, 1403/03/24
Update count: 0
Registration date
2024-06-13, 1403/03/24
Registrant information
Name
Alireza Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1432
Email address
a.jalalll85@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2025-06-10, 1404/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the effect of ketorolac 30 mg intravenous and haloperidol 5 mg intravenous in reducing the intensity of primary headache in patients with the chief complaint of headache at the emergency department of Sina Hospital.
Public title
Comparison of ketorolac and haloperidol in headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18 to 55 who have visited the emergency room with the main complaint of headache.
Exclusion criteria:
Abnormal blood pressure(>200/100 mmhg) thunderclap (normal to the worst pain due to short time) fever acute trauma history of brain mass history of stroke history of anatomic malformation of brain Qtc>450 ms in EKG altered mental status (GCS<15) Haloperidol allergy Ketorolac allergy airway disease such as asthema active peptic ulcer advanced renal failure recent major sergury new FND any suspicious which lead to use of CT scan or LP pregnancy QT interval prolong drugs hepatic failure epilepsy or history of seizure hyperthyroidism parkinsonism chronic psychiatrics disease Concomitant use or within 2 weeks of discontinuing an MAOI inhibitor active gastritis history of GI bleeding Previous participation in the same study Previous enrollment in a study that may interfere with the current study Lack of consent to participate in the study Unwillingness to sign the consent form
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 12
Randomization (investigator's opinion)
Randomized
Randomization description
Grouping of patients based on the balanced block randomization method will be done in groups A and B. First, blocks of 4 including 6 modes are defined and a number from 1 to 6 is considered by the executive supervisor of the plan for each of these blocks and the number of blocks is determined based on the number of the determined sample volume and the number of the desired blocks is cast. and the last patient will be determined in order and the randomized list will be provided to the project manager in order. At each visit, the patients will be entered into two groups A and B based on the previously determined order. This process continues until the examination of the last patient based on the specified sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The pharmacist covers the ampoules with labels and puts them in the envelope. (He knows the type of ampoule in each envelope) Then he picks the envelopes according to the random sequence given to him and delivers them to the researcher. In the following, envelopes will be used for the participants in order (for example, the first patient envelope number 1 and the fifth patient envelope number 5). In this way, it is ensured that the patients and health care providers who prescribe the drugs and the outcome examiners (pain score and possible complications) are not aware of which intervention group they are placed in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Sina hospital - Tehran university of medical science
Street address
Imam Khomeini St. Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2023-12-03, 1402/09/12
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.106

Health conditions studied

1

Description of health condition studied
Headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes

Primary outcomes

1

Description
pain reduction
Timepoint
15 , 30 , 60 mintes
Method of measurement
Visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Ketorolac prescription 30 mgr intravenous with 30 mgr/2mL ampoules by 5 cc syringes
Category
Treatment - Drugs

2

Description
Intervention group2: Haloperidol receivers 1 mgr intravenous with 2mgr ampoules diluted in 5 cc sterile water in 5cc syringes
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Alireza Jalali
Street address
Imam Khomeini
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1432
Email
a.jalalll85@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Rezaee
Street address
Medicine faculty , Poursina ave, Qods avenue, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6641 8466
Email
deanmed@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences research
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
Alireza Jalali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomein
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1432
Email
a.jalalll85@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Jalali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1432
Email
a.jalalll85@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Jalali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1432
Email
a.jalalll85@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
part of data ; main consequences , adverse consequences
When the data will become available and for how long
6 months after publish
To whom data/document is available
Physician
Under which criteria data/document could be used
request permission
From where data/document is obtainable
to researcher
What processes are involved for a request to access data/document
email to researcher
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