Prophylactic treatment with oral diazepam to prevent recurrence of febrile seizures following triple vaccination with DTP and MMR: Randomize Controlled Trial
Prophylactic treatment with oral diazepam to prevent recurrence of febrile seizures following DTP and MMR vaccination: Randomized controlled trial
Design
This study is a double-blind clinical trial with parallel groups using randomized block method, and sampling is done by available method among patients with a history of febrile seizures following vaccine injection, in both intervention and control groups, and the sample size in each group was 30 patients.
Settings and conduct
This study will be performed on 60 patients with a history of febrile seizures following vaccination referred to Abuzar and Golestan hospitals in Ahvaz. The patients will be randomly divided into two groups based on a random table of computer generated numbers, and one group will receive oral diazepam and the other group will receive only diazepam anal rescue tube therapy and will not receive prophylactic treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 6 months to 6 years old who have had a seizure following vaccination and have no contraindications to vaccination.Patients with immunodeficiency, cancer, and patients taking corticosteroids are not included in the study.
Exclusion criteria: Parental dissatisfaction, removal of the vaccine from the patient's vaccination schedule for any reason, history of oral diazepam allergy,Having contraindications for the MMR and DTP vaccines
Intervention groups
The intervention group in our study included individuals receiving oral diazepam.
The control group received only salvage therapy with diazepam rectal tube.
Main outcome variables
The incidence of fever and also seizure at the time after the injection of the vaccines
Occurrence of complications such as drowsiness, dizziness, hypotension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210619051624N1
Registration date:2021-09-29, 1400/07/07
Registration timing:registered_while_recruiting
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
Shahram Nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4228 5146
Email address
nasiri-sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic treatment with oral diazepam to prevent recurrence of febrile seizures following triple vaccination with DTP and MMR: Randomize Controlled Trial
Public title
Treatment with Oral Diazepam for Prevention of Recurrence of Seizures following DTP and MMR Vaccination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 6 months to 6 years old who have had a seizure following the vaccine
There are no contraindications to vaccination.Patients with immunodeficiency, cancer, and patients taking corticosteroids are not included in the study.
Exclusion criteria:
Parental dissatisfaction
Remove the vaccine from the patient's immunization schedule for any reason
History of oral diazepam allergy
Having contraindications for the MMR and DTP vaccines
Age
From 6 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individuals are randomly divided into two groups based on four random block permutations. Also, in order to prevent confounding factors as well as reduce the bias caused by the opinions of the project guiding researchers, researchers involved in the levels of random sequencing, enrollment in terms of entry and exit criteria, assigning participants to the target groups will work separately.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this clinical trial, patients will be randomly divided into two groups based on a randomly generated table of computer-generated numbers, with one group receiving oral diazepam and the other group (control) receiving only life-saving diazepam anal tube therapy. And will not receive preventive treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-12-29, 1399/10/09
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.037
Health conditions studied
1
Description of health condition studied
Febrile seizures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Numbers of seizure
Timepoint
After vaccination
Method of measurement
By asking parents of patients
2
Description
Number of fevers
Timepoint
After vaccination
Method of measurement
By asking parents of patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group that will be treated with oral diazepam, and in addition to rectal Diazpam tube, Diazepam tablets are received from Sobhan Company at a dose of 1 mg per kg for the first 48 hours of the vaccine injection.
Category
Prevention
2
Description
Control group:The group that will only receive life-saving treatment with diazepam rectal tube in case of seizures lasting more than 2 to 5 minutes and will not receive preventive treatment.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Aboozar Children's Hospital
Full name of responsible person
Shahram Nasiri
Street address
Zeitoon Karmandi Ave
City
Ahvaz
Province
Khouzestan
Postal code
1417561636
Phone
+98 61 3444 9003
Email
karami.9926@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Nasiri
Street address
Zeitoon karmandi, Aboozar Children's Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1417561636
Phone
+98 61 3444 9003
Email
nasiri-sh@ajums.ac.ir
Grant name
Ahvaz Jundishapur University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Kordnezhadian
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Zeitoon Karmandi, Aboozar Children's Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1417561636
Phone
+98 61 3444 9003
Email
karami.9926@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Nasiri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Zeitoon Karmandi, Aboozar Children's Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1417561636
Phone
+98 61 3444 9003
Email
nasiri-sh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Kordnezhadian
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Zeitoon Karmandi, Aboozar Children's Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1417561636
Phone
+98 61 3444 9003
Email
karami.9926@gmail.com
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
No - There is not a plan to make this available
Title and more details about the data/document
Only the results of the whole data are made available to the public
When the data will become available and for how long
Starting 9 months after publication
To whom data/document is available
Information is provided to Ahvaz University of Medical Sciences
Under which criteria data/document could be used
The use of data is merely intended to introduce the study and examine how the parameters are measured
From where data/document is obtainable
Dr. Shahram Nasiri (Project Manager)
What processes are involved for a request to access data/document