Efficacy of oral mefenamic acid, paracetamol and placebo for analgesic prophylaxis in childhood vaccination: A three arm, parallel, triple-blind Randomized Controlled Trial

Immunization is a crucial part of disease prevention in childhood which is having a long-term positive impact.  Immunization is also accompanied by fear of getting vaccinated with needles and associated pain with it. Pain is usually underrated for pediatric population. Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAIDs). NSAIDs are most effective and commonly used analgesic for acute pain. it is widely used anti-pyretic, anti-analgesic and anti-inflammatory drug in children. The Face Leg Activity Cry Consolability (FLACC) scale has five parameters to look for face, leg, activity, cry, consolability. Each of these parameters are ranked on three point scale(0-2) as per response severity and together all scores add up to 0-10. It is valid, reliable and easy to administer scale for post- procedural pain measurement in children from 2 months to 7 years of age. Although mefenamic acid and other NSAIDs like paracetamol is very frequently prescribed as analgesic and anti-pyretic post-vaccination but there is no published study for use of mefenamic acid as prophylactic analgesic for vaccination procedural pain. so this study is planned to find out the role of mefenamic acid as prophylaxis for analgesia during vaccination. It is a randomized controlled triple blind trial. Aim: To study the efficacy of mefenamic acid as analgesic prophylaxis in pain management in children during vaccination. The participants in both groups will be enrolled by block randomization list generated by computer randomization software. Drug and placebo in both groups will be coded as A/B having similar physical properties. Each participant will be given drug as per their allocation. Vaccination as per National Immunization Schedule will be given to participants 30 minutes after drug administrated. FLACC scoring will be done during and 30 minutes after vaccination administration by the same person. Person who will be doing intervention, administrating drug, vaccinating, scoring and statistician all will be blinded. Concealment will be disclosed after results will have been locked.