Effectiveness and safety of intranasal fentanyl for pain management in infants aged 0–6 months: a systematic review protocol
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.017 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".