Trial design and protocol of randomized controlled trial evaluating the efficacy of a non-invasive topical pain numbing device for prophylactic analgesia during routine vaccination in children

Swetha Madhuri Pulla; Jyothi Naik; Thirunavukkarasu Arun Babu

doi:10.18203/2349-3259.ijct20260049

Authors

Swetha Madhuri Pulla Department of Paediatrics, AIIMS, Mangalagiri, Andhra Pradesh, India
Jyothi Naik Department of Paediatrics, AIIMS, Mangalagiri, Andhra Pradesh, India
Thirunavukkarasu Arun Babu Department of Paediatrics, AIIMS, Mangalagiri, Andhra Pradesh, India https://orcid.org/0000-0003-1123-5270

DOI:

https://doi.org/10.18203/2349-3259.ijct20260049

Keywords:

Vaccination, Children, FLACC score, Pain relief, Randomized trial

Abstract

Background: Pain associated with vaccination is a common cause of anxiety among children and their parents. While pharmacological and non-pharmacological interventions have been explored to reduce pain, their use is not widespread in practice. Cryoanalgesia using a non-invasive pain numbing device is a novel approach that has shown promise during minor procedures.

Methods: This is a prospective, double-blinded, randomized controlled trial evaluating the efficacy and safety of a non-invasive topical pain numbing device in reducing pain during routine childhood vaccination. Children aged 6 months to 10 years presenting to the pediatric OPD for immunization will be recruited. Participants will be randomly allocated to either the intervention (device) or control (sham device) group using block randomization. Pain will be assessed using the FLACC scale at 0-, 5- and 15-minutes post-vaccination.

Conclusions: If the device proves effective in reducing vaccination-associated pain, it could be implemented widely to improve vaccine compliance and reduce vaccine hesitancy.

Trial Registration: Clinical trials registration number is CTRI/2025/03/083734.

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