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Recruiting NCT06832046

Evaluation of the "Intranasal Fentanyl" Protocol in Pediatric Surgical Emergencies at Strasbourg University Hospital

Observational Musculoskeletal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Musculoskeletal Pain. Basic parameters: 1 year — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Emergency trauma departments receive thousands of patients each year whose main symptom is pain. In recent years, intranasal fentanyl (FIN) has entered the therapeutic arsenal to treat pain in the emergency department. Various studies have validated its effectiveness for musculoskeletal pain as well as its tolerance and safety of use. Since then, new protocols have been implemented including this treatment. In This study, the investigators propose to retrospectively study the quality of prescription of intranasal fentanyl in the treatment of pain in the emergency department and the quality of monitoring of this treatment in current practice.

Primary outcome measures

  • The judgment criterion is composite in order to retrospectively evaluate the relevance of the prescription, administration and monitoring of the intranasal fentanyl (FIN) protocol. [Time frame: Up to 2 years]
  • The judgment criterion is composite in order to retrospectively evaluate the relevance of the prescription, administration and monitoring of the intranasal fentanyl (FIN) protocol.The judgment criterion includes, [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • Child < 18 years old
  • Child treated in the pediatric emergency department of Strasbourg University Hospital
  • Child who has benefited from intranasal fentanyl between 08/01/2022 and 09/31/2024.
  • Child (and/or his/her parental authority) who has not expressed, after information, his/her (their) opposition to the reuse of his/her health data for the purposes of this research.

Exclusion criteria

  • Refusal of the child (and/or his/her parent) to participate in the study
  • Patient's medical file not incomplete
  • Child not domiciled in France.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Service d'Urgences Médico-Chirurgicales Pédiatriques - CHU de Strasbourg - France — Strasbourg

Identifiers

NCT: NCT06832046 · 9480

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗