Clinical trial of evaluation of 18th month of age vaccines injection order (intramuscular first and then subcutaneous or subcutaneous first and then intramuscular) on pain of intramuscular injection of diphtheria, pertussis and tetanus vaccine
This clinical trial will be done to answer this question that whether intramuscular injection of diphtheria, pertussis and tetanus (DPT) vaccine first and then subcutaneous injection of measles, mumps and rubella (MMR) vaccine or subcutaneous injection of MMR vaccine first and then intramuscular injection of DPT vaccine, can cause less pain of DPT vaccine intramuscular injection. In a clinical trial, sixty healthy 18 month old children who will be referred for vaccination to Primary Health Care Center of Akbari in Yazd, Iran will be randomly distributed into two groups. In group I, intramuscular DPT vaccine will be injected first and then subcutaneous injection of MMR will be done and in group II, children will receive subcutaneous injection of MMR vaccine first and then intramuscular injection of DPT vaccine. In all of them, vaccines will be injected in similar conditions and by a trained person. Primary outcomes include pain score during DPT vaccine injection, pain score during MMR vaccine injection and obtaining of pain score of less than four during DPT vaccine injection. Pain score when the needle is inserted to the skin will be assessed based on Modified Behavioral Pain Scale. Secondary outcome will be duration of baby crying during DPT vaccine injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409042639N14
Registration date:2014-10-10, 1393/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-10, 1393/07/18
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran
Expected recruitment start date
2014-08-26, 1393/06/04
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of evaluation of 18th month of age vaccines injection order (intramuscular first and then subcutaneous or subcutaneous first and then intramuscular) on pain of intramuscular injection of diphtheria, pertussis and tetanus vaccine
Public title
Effect of the order of injecting 18th month of age vaccines on pain
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 18 months of age, being in a healthy medical condition and referring for vaccination to primary health care center
Exclusion criteria: neurodevelopmental delay, severe congenital malformation and receiving sedative hypnotic drugs within the past 24 hours
Age
From 1 year old to 1 year old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The children in this trial will be randomized by random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
central building of university, Bahonar square
City
Yazd
Postal code
Approval date
2014-08-24, 1393/06/02
Ethics committee reference number
17/1/107183/پ
Health conditions studied
1
Description of health condition studied
vaccination
ICD-10 code
Z27
ICD-10 code description
Need for immunization against combinations of infectious diseases
Primary outcomes
1
Description
pain score during diphtheria, pertussis and tetanus (DPT) vaccine injection
Timepoint
time of needle insertion to skin
Method of measurement
Modified Behavioral Pain Scale table
2
Description
pain score during measles, mumps and rubella (MMR) vaccine injection
Timepoint
time of measles, mumps and rubella (MMR) vaccine injection
Method of measurement
Modified Behavioral Pain Scale table
3
Description
obtaining of pain score of less than four during diphtheria, pertussis and tetanus (DPT) vaccine injection
Timepoint
time of diphtheria, pertussis and tetanus (DPT) vaccine injection
Method of measurement
Modified Behavioral Pain Scale table
Secondary outcomes
1
Description
duration of baby crying after injection of DPT vaccine
Timepoint
every 10 seconds after vaccine injection until stopping of crying
Method of measurement
by chronometer
Intervention groups
1
Description
intramuscular injection of a single dose of DPT (diphtheria, pertussis and tetanus) vaccine and then subcutaneous injection of a single dose of combination of measles, mumps and rubella vaccines
Category
Prevention
2
Description
subcutaneous injection of a single dose of combination of measles, mumps and rubella vaccines and then intramuscular injection of a single dose of DPT (diphtheria, pertussis and tetanus) vaccine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Primary Health Care Center of Akbari
Full name of responsible person
Dr.Hossein Gholami
Street address
Timsar Fallahi Street , Emam Hassan square,Safaeeh,Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran
Full name of responsible person
Dr.Fatemah Ezoddini
Street address
central building of university , Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran
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
Shahid Sadoughi University of Medical Sciences , Yazd , Iran