Introduction In pediatric intensive care units, pain, sedation, delirium, and iatrogenic withdrawal syndrome must be managed as interrelated conditions. Existing clinical practice guidelines have some methodological limitations and are not readily transferrable to the European context without adaptation. This protocol describes the methods for developing a high-quality, and the first patient- and family-informed European guideline for managing pain, sedation, delirium and iatrogenic withdrawal syndrome. Methods The guideline will be developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) - ADOLOPEMENT approach, engaging clinical experts and patients and families in the development process. It will consist of seven phases: 1) Set-up – establishing three groups for guideline development: i) steering committee, ii) development panel (experts and patient/family partners from across Europe), and iii) patient and family advisory panel, and scoping to determine population, conditions, purpose, and users of the guideline; 2) Preparation – voting on summary recommendations, prioritizing research questions and outcomes, and matching research questions with existing recommendations; 3) Search and retrieval of evidence – using three search approaches to develop search strategies to find evidence, conducting individualized searches for each summary recommendation and new research question, selecting evidence, study appraisal, and initial data extraction; 4) Evidence synthesis – summarizing evidence in evidence profiles and summary of evidence tables, and conducting panel surveys of current practice when evidence is absent; 5) Development – drafting recommendations, voting on and approving them, and developing accompanying materials; 6) Review – conducting internal, society-level, and external international expert reviews; and 7) Issue – publishing the guideline. Discussion This protocol ensures a transparent process follows the GRADE approach for guideline development, leading to a high-quality, trustworthy, and credible guideline for managing pain, sedation, delirium and iatrogenic withdrawal syndrome in critically ill children. Tailored to the European context for healthcare professionals.
