Publication:

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

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 weeks 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.