Evidence map›Paper›PMID 41474463›Full record

ArticleEthics & human research

Pain Management Research in Prehospital Settings: The Pain of Exception from Informed Consent.

Michael Linke, Francis X Guyette, Jason McMullan

Abstract read
In one paragraph

Article in Ethics & human research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Michael LinkeAdjunct professor in the Department of Internal Medicine at the University of Cincinnati.
Francis X GuyetteProfessor in the Department of Emergency Medicine at the University of Pittsburgh.
Jason McMullanProfessor in the Department of Emergency Medicine at the University of Cincinnati.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Effective pain management in prehospital settings remains a significant challenge, particularly for patients with acute trauma. This report examines the complexities of conducting prehospital pain studies, focusing on two clinical trials as case studies. The first trial implemented a novel two-step informed consent process, which, despite its innovation, faced logistical challenges and introduced biases favoring the enrollment of less severely injured patients. The second study, conducted under the federal regulatory pathway for Exception from Informed Consent (EFIC), successfully addressed consent challenges but restricted enrollment to severely injured patients to meet EFIC regulatory requirements. Both studies excluded women of childbearing age due to concerns about fetal safety. These limitations underscore the urgent need for regulatory revisions to expand research with alteration of informed consent, enabling the development of new interventions for prehospital pain management.

Indexed as

Biomedical ResearchEmergency Medical ServicesInformed ConsentPain ManagementPatient SelectionAdultFemaleHumansMaleWounds and Injuriesemergency medicine researchfentanylhuman research ethicshuman research regulationshuman subjects researchinjuryketaminepain managementtrauma

Identifiers

PMID41474463
PMCPMC12755289

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.