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OpenTrials
Completed

NCT Number: NCT07455305

The Effect of Simultaneous Versus Sequential Intramuscular Vaccine Injections on Pain Levels in Infants

This study was designed as a randomized controlled trial comparing simultaneous and sequential administration of intramuscular vaccines in infants.

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Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University

Istanbul, İ̇stanbul, 34500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simultaneous injection

Other

Two trained pediatric nurses administered the vaccines simultaneously into different thighs (vastus lateralis muscles) following a coordinated countdown.

Sequential injection

Other

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.

Primary outcomes

  1. Pain was assessed using the FLACC

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect of Simultaneous Versus Sequential Intramuscular Vaccine Injections on Pain Levels in Infants: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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