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The Effect of Adding Intravenous Midazolam to Apotel®in Treatment of Patients with Primary Headache Referred to Emergency Department

Protocol summary

Summary
1) Objectives: This research will be accomplished with the purpose of the effect of Adding Intravenous Midazolam to Apotel® in Treatment of Patients with Primary Headache Referred to Emergency Department 2) Design: 120 patients with primary headache will be divided two groups [Apotel plus Midazolam (group 1), Apotel (group 2)] with use Random Allocation Software. 3) Setting and conduct: After obtain the informed consent, severity of patient’s headache, will be registered with using NAS. Then patient will be treated based on group number (1 or 2). 4) Participants including major eligibility criteria: inclusion criteria: All 18-65 years old patients with primary headache (Migraine or tension). Exclusion criteria: Sensitivity to used medicine, secondary type headache, vomiting, pregnancy, loss of consciousness, hepatic failure, breast-feeding, renal failure, psychotic disorder, get a medicine before arriving to emergency ward, dissatisfaction to participate to study. 5) Intervention: Type of treatment used in two groups are different. In group one Apotel plus Midazolam, and in group two Apotel will be used. 6) Main outcome measures variables: Duration of pain relief will be compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016013112592N3
Registration date: 2016-08-18, 1395/05/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-18, 1395/05/28
Registrant information
Name
Farzad Rahmani
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 2078
Email address
rahmanif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Adding Intravenous Midazolam to Apotel®in Treatment of Patients with Primary Headache Referred to Emergency Department
Public title
Effect of adding sedative agent to analgesics for headache treatment
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: All 18-65 years old patients with primary headache (Migraine or tension). Exclusion criteria: Sensitivity to used medicine, secondary type headache, vomiting, pregnancy, loss of consciousness, hepatic failure, breast-feeding, renal failure, psychotic disorder, get a medicine before arriving to emergency ward, dissatisfaction to participate to study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.TBZMED.REC.1395.325

Health conditions studied

1

Description of health condition studied
Headache
ICD-10 code
G44.1, G44
ICD-10 code description
migraine and other headache syndromes

Primary outcomes

1

Description
Duration of pain relief
Timepoint
The time between medicine prescription and pain releif
Method of measurement
With stopwatch

Secondary outcomes

1

Description
Patient satisfaction
Timepoint
After the end of treatment, we will ask from patient about satisfaction of treatment
Method of measurement
Visual Analog Scale. This scale contains 1-10 scores that score 1 shows dissatisfaction and score 10 show excellent satisfaction

Intervention groups

1

Description
Intervention group 1: In this group, Midazolam (1cc, 5 mg, Darou pakhsh, Tehran, IR Iran) 0.02 mg/kg plus Apotel (1 gr, 6.7 cc, cobel darou, Tehran, IR Iran) 15 mg/kg (up to 1 gr) will be used intravenously.
Category
Treatment - Drugs

2

Description
Intervention group 2: In this group, Apotel (1 gr, 6.7 cc, cobel darou, Tehran, IR Iran) 15 mg/kg (up to 1 gr) will be used intravenously.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Farzad Rahmani
Street address
Azadi Avenue, between Maralan and Hafez.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor / Emergency Medicine Specialist
Other areas of specialty/work
Street address
Azadi Avenue, between Maralan and Hafez, Sina Hospital, Emergency Ward
City
Tabriz
Postal code
Phone
+98 41 3549 8144
Fax
Email
rahmanif@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor / Emergency Medicine Specialist
Other areas of specialty/work
Street address
Azadi Avenue, between Maralan and Hafez, Sina Hospital, Emergency Ward
City
Tabriz
Postal code
Phone
+98 41 3549 8144
Fax
Email
rahmanif@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor / Emergency Medicine Specialist
Other areas of specialty/work
Street address
Azadi Avenue, between Maralan and Hafez, Sina Hospital, Emergency Ward
City
Tabriz
Postal code
Phone
+98 41 3549 8144
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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