Effect of the order of injecting 18th month of age vaccines on pain

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT201409042639N14
• Date of registration: 2014-10-10
• Prospective Registration: No
• Primary sponsor: Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran
• Public title: Effect of the order of injecting 18th month of age vaccines on pain
• 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
• Date of first enrolment: 2014-08-26
• Target sample size: 60
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/2446
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: The children in this trial will be randomized by random numbers table.
• Phase: 1

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr.Razieh Fallah
• Affiliation: Shahid Sadoughi University of Medical Sciences , Yazd , Iran

• Name: Dr. Hosein Gholami
• Affiliation: Shahid Sadoughi University of Medical Sciences , Yazd , Iran

Key inclusion & exclusion criteria

Inclusion 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
Exclusion criteria:

Age minimum: 1 year
Age maximum: 1 year
Gender: Both

Health Condition(s) or Problem(s) studied

Need for immunization against combinations of infectious diseases

vaccination.
Need for immunization against combinations of infectious diseases

Intervention(s)

Prevention

Intervention 1: 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. Intervention 2: 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.

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

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

Primary Outcome(s)

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.

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.

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.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Shahid Sadoughi University of Medical Sciences, Yazd, Iran