Investigation of the effect of Midazolam prophylaxis on the incidence of idiosyncratic seizures caused by tramadol consumption
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. Patients will be randomly divided into 2 groups based on 7 blocks. The sample size for each study group is 14.
Settings and conduct
In this study, all patients referred to Ali Asghar Hospital in Shiraz, due to tramadol use will be enrolled. Patients will be randomly divided into 2 groups based on 7 blocks. The sample size for each study group is 14. A total of 28 patients will be examined. Patients and data analyzer will be blind.
Participants/Inclusion and exclusion criteria
In this study, all patients referred to Ali Asghar Hospital in Shiraz, due to tramadol usage will be enrolled.
Inclusion criteria: Age over 16 years, No seizures before entering the study.
Exclusion criteria: Age over 70 years, History of epilepsy, Concomitant usage of antidepressants, Concomitant usage of other drugs with a dose of poisoning, History of underlying diseases, Trauma to the head.
Intervention groups
In intervention group, Midazolam will be given as an infusion at a dose of 0.05 mg / kg for 6 hours. In control group, Control group: Normal saline will be given an infusion for 6 hours.
Main outcome variables
Seizures, Number of seizures, Length of hospital stay, Need for mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180608040013N2
Registration date:2020-04-22, 1399/02/03
Registration timing:prospective
Last update:2020-04-22, 1399/02/03
Update count:0
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Najmeh Zarei jelyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 2747
Email address
n_zarei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Midazolam prophylaxis on the incidence of idiosyncratic seizures caused by tramadol consumption
Public title
effect of Midazolam prophylaxis on the seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Take tramadol tablets for the past 6 hours
Age over 16 years
No seizures before entering the study
Exclusion criteria:
Age over 70 years
History of epilepsy
Concomitant use of antidepressants
Concomitant use of other drugs with a dose of poisoning
History of underlying diseases
Trauma to the head
Age
From 16 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 8 person. In each block, 4 individuals will be in intervention group and 4 will be in control group. A total of 7 blocks will be considered for sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data will be analyzed by person who is blind to study groups. The therapist and patients will also be unaware of the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Karim khan zand Ave, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.SUMS.MED.REC.1398.004
Health conditions studied
1
Description of health condition studied
Seizures
ICD-10 code
F44.5
ICD-10 code description
Conversion disorder with seizures or convulsions
Primary outcomes
1
Description
Seizures
Timepoint
Up to 24 hours after hospitalization
Method of measurement
Based on the patient's records and interview with the patient in case of discharge before 24 hours
2
Description
Number of seizures
Timepoint
Up to 24 hours after hospitalization
Method of measurement
Based on the patient's records and interview with the patient in case of discharge before 24 hours
3
Description
The length of hospital stay
Timepoint
From hospitalization to discharge
Method of measurement
Based on patient records
4
Description
Need for mechanical ventilation
Timepoint
From hospitalization to discharge
Method of measurement
Based on patient records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Midazolam will be given an infusion at a dose of 0.05 mg / kg for 6 hours.
Category
Treatment - Drugs
2
Description
Control group: Normal saline will be given an infusion for 6 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Medical and Educational Center
Full name of responsible person
Najmeh Zarei Jelyani
Street address
Meshkin Fam Street, Hazrat Ali Asghar Medical and Educational Center
City
Shiraz
Province
Fars
Postal code
7143918796
Phone
+98 71 3228 8602
Email
aliasghar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadjavad Ashraf
Street address
Karim Khan-e-Zand Ave, ُShiraz University of medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3647 4952
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Zarei Jelyani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Karim Khan-e-Zand Ave, Namazi hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3630 2747
Email
n_zarei@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Zarei Jelyani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Karim Khan-e-Zand Ave, Namazi hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3630 2747
Email
n_zarei@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Zarei Jelyani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Karim Khan-e-Zand Ave, Namazi hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3630 2747
Email
n_zarei@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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