Injection Pain, Injection Pain Prevention
Conditions
Keywords
sequential injection, simultaneous injection
Brief summary
This study was designed as a randomized controlled trial comparing simultaneous and sequential administration of intramuscular vaccines in infants.
Detailed description
The study was carried out in the pediatric outpatient vaccination clinic of a private hospital in Istanbul, Türkiye, between 1 September and 15 November 2021. Infants were eligible if they were younger than 12 months, required two routine intramuscular vaccines during the same visit, and were accompanied by a parent or legal guardian able to provide informed consent. Infants were excluded if they had received analgesics within six hours prior to vaccination, received vaccines other than hepatitis B, pentavalent combination vaccine (DTaP-IPV/Hib), or pneumococcal conjugate vaccine, or had known neurological, developmental, or motor impairments. Infants were randomly assigned in a 1:1 ratio to either the simultaneous injection group or the sequential injection group using computer-generated randomization (www.randomizer.org). Allocation was completed prior to the vaccination procedure. A total of 150 infants were assessed for eligibility; 40 did not meet inclusion criteria. The final sample included 110 infants (55 per group). No participants were lost to follow-up.
Interventions
OTHERSimultaneous injection
Two trained pediatric nurses administered the vaccines simultaneously into different thighs (vastus lateralis muscles) following a coordinated countdown.
OTHERSequential injection
A single nurse administered the two vaccines consecutively into different thighs. A pause of approximately 10-15 seconds between injections allowed the infant to settle.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
All assessments were performed by the same experienced pediatric nurse who was not part of the research team and was unaware of the study hypotheses.
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes
Inclusion criteria
* The following criteria were determined: the child was ordered to receive two of the routine childhood IM vaccines (hepatitis B, quintuple combination vaccine, pneumococcal vaccine), the parents were willing to participate in the study, the child had not received painkillers in the last 6 hours, and the child did not have mental and motor retardation.
Exclusion criteria
* It was determined that the child should be 1 year of age or older, the vaccines other than the quintuple mixed vaccine, Pneumococcal vaccine and Hepatitis B vaccine should have been ordered by the physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain was assessed using the FLACC | Time Frame: Baseline; During injection (periprocedural); Immediately after injection (within 1 minute) | The scale has 5 behavioral assessment categories (facial expression, leg movement, activity, crying, consolability). Each category consists of three items and is scored between 0 and 2 points. The total scale score ranges from 0 to10, with higher scores indicating greater pain intensity. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORSevil Inal
Istanbul University - Cerrahpasa
Outcome results
None listed