Helen McCord, Melissa Rothfus, Tim Disher, Nadeana Norris, Karlee Jones, Laila Kristoffersen, Maria Syverud, Marsha Campbell-Yeo
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The potential benefits of intranasal fentanyl are notable, but comprehensive guidelines for its use in infants is lacking.</p><p><strong>Inclusion criteria: </strong>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.</p><p><strong>Methods: </strong>This review will adhere to the JBI methodology for systematic reviews and the Preferred Reporting Items Form Systematic Review and Meta-Analysis Protocols (PRISMA) guidelines. A 3-step search strategy will be used to search databases (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 with 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.</p><p><strong>Systematic review registration number: </strong>PROSPERO CRD42024551524.</p>","PeriodicalId":36399,"journal":{"name":"JBI evidence synthesis","volume":" ","pages":""},"PeriodicalIF":1.5000,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and safety of intranasal fentanyl for pain management in infants aged 0-6 months: a systematic review protocol.\",\"authors\":\"Helen McCord, Melissa Rothfus, Tim Disher, Nadeana Norris, Karlee Jones, Laila Kristoffersen, Maria Syverud, Marsha Campbell-Yeo\",\"doi\":\"10.11124/JBIES-24-00376\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Introduction: </strong>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.</p><p><strong>Inclusion criteria: </strong>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. 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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.
Inclusion 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 Form Systematic Review and Meta-Analysis Protocols (PRISMA) guidelines. A 3-step search strategy will be used to search databases (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 with 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.
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