A protocol to develop a standard guideline for neonatal pain management.

backgroundHospitalized newborns experience a high frequency of painful procedures. Undertreated pain has a series of adverse physical and psychosocial effects on newborns. Guidelines successfully applied in clinical practice can effectively improve pain management in NICUs and reduce the incidence of pain. Neonatal care providers in China are in urgent need of a high-quality, evidence-based guideline for the treatment and management of neonatal pain. The National Clinical Research Center for Child Health and Disorders is leading the development of a standard guideline for neonatal pain management suitable for the medical environment in China providing empirical support and safety guarantees for clinical practice. The WHO Collaborating Centre for Guideline Implementation and Knowledge Translation will provide technical support and guidance. The purpose of this paper is to outline the detailed methodology and technical route of guideline development.

methodsWe will follow the WHO principles and methods for the formulation of standard guidelines. The critical steps for developing the guideline are as follows: (I) definition of the guideline Scope; (II) establishment of guideline working groups; (III) selection of the clinical questions; (IV) performance of systematic reviews; (V) grading the quality of the body of evidence; and (VI) formulating recommendations and reaching consensus. DISCUSSION: This protocol would ensure that the process of guideline development is normative, scientific, and transparent. The standard guideline for neonatal pain management based on the available high-quality evidence and tailored to the Chinese health care system will help neonatal caregivers in NICUs effectively manage neonatal pain. GUIDELINE REGISTRATION: The guideline was registered at the International Practice Guidelines Registry Platform. The registration No. is IPGRP-2021CN044.