A STUDY PROTOCOL FOR A DOUBLE-ARM RANDOMISED CONTROLLED TRIAL TO EVALUATE THE ANAESTHETIC EFFICACY OF A NOVEL TOPICAL AYURVEDIC EMULGEL DURING NEONATAL VENIPUNCTURE

Background:Effective pain management in neonates during procedures such as venipuncture is critical to minimise potential adverse neurodevelopmental and psychological consequences. Conventional synthetic topical anaesthetics, while effective, may pose safety concerns in this vulnerable population. This study protocol proposes to evaluatea novel topical ayurvedic emulgel (NTAE) containing Anacyclus pyrethrum(Akarkarabha) and Syzygium aromaticum(Lavanga) as a potentially safer alternative to standard lidocaine–prilocaine cream (LPC) for neonatal venipuncture.Objectives:The primary objective is to evaluatethe anaesthetic efficacy of NTAE in reducing pain during venipuncture in neonates. Secondary objectives include comparisonwith LPC and assessment of the incidence of local adverse effectsfollowing topical anaesthetic application.Methods:This will bea single-centre, prospective, randomised-controlled, parallel-group, single-blind clinical trial. A maximum proposed sample size of one hundred neonateswill be randomly assignedto either the intervention group receiving NTAE or the control group receiving LPC. The trial will be conducted in two phases based on application duration: Phase I (30-minute application) and Phase II (60-minute application), in accordance with the revised IEC-approved protocol. The study drug will compriseAnacyclus pyrethrumethanol extract and Syzygium aromaticumoil formulated as an emulgel using standardised procedures. Pain will be assessedusing the Neonatal Infant Pain Scale (NIPS) and the Neonatal Facial Coding System (NFCS), along with monitoring of physiological parameters such as heart rate and oxygen saturation.Conclusion:This study protocol aims to generate evidenceregarding the feasibility, efficacy, and safety of an ayurvedic topical anaesthetic formulation for neonatal venipuncture and may inform the design of future integrative and multicentric clinical trialsin neonatal pain management.