Effectiveness and safety of intranasal fentanyl for pain management in infants aged 0-6 months: a systematic review protocol.

OBJECTIVE

This review aims to assess and synthesize the existing literature on the effectiveness and safety of intranasal fentanyl versus no intervention, placebo, non-pharmacological, or pharmacological interventions for pain management in infants aged 0-6 months.

INTRODUCTION

Pain management in infants, especially given their exposure to frequent painful procedures, is a crucial concern. The potential benefits of intranasal fentanyl are notable, but comprehensive guidelines for its use in infants is lacking.

ELIGIBILITY CRITERIA: This review will include experimental and non-experimental quantitative studies comparing intranasal fentanyl, at any dose/frequency, for pain management in infants aged 0-6 months, against comparators such as no intervention, placebo, or other pharmacological and non-pharmacological interventions. Procedures will include those considered to be tissue-breaking, needle-related, non-tissue-breaking, or any procedure deemed to be painful. The primary outcome will be pain intensity during procedures, chosen for its relevance in evaluating the effectiveness of intranasal fentanyl. Secondary outcomes will include pain response, recovery, frequency of repeated dosing, and safety. Studies in any language will be considered.

METHODS

This review will adhere to the JBI methodology for systematic reviews and the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. A 3-step search strategy will be used to search databases (Cochrane Library, MEDLINE, Embase, CINAHL, Scopus) without date restrictions. The search results will be reported in a PRISMA flow diagram. Two independent reviewers will extract detailed data on participants, methods, interventions, and outcomes. Certainty will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) and JBI appraisal tools to evaluate study quality and bias risk. Data synthesis will combine findings using statistical models, or narrative summaries when meta-analysis is not feasible.

REVIEW REGISTRATION: PROSPERO CRD42024551524.