Koç University
Istanbul, İ̇stanbul, 34500, Turkey (Türkiye)
NCT Number: NCT07455305
This study was designed as a randomized controlled trial comparing simultaneous and sequential administration of intramuscular vaccines in infants.
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Notify MeUp to 12 month
All sexes
Interventional
Not applicable
Istanbul, İ̇stanbul, 34500, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two trained pediatric nurses administered the vaccines simultaneously into different thighs (vastus lateralis muscles) following a coordinated countdown.
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.
Time frame: 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.
Istanbul University - Cerrahpasa
Other
The Effect of Simultaneous Versus Sequential Intramuscular Vaccine Injections on Pain Levels in Infants: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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