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Clinical Trials in France / NCT06832046
Recruiting Observational

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

NCT06832046 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Observational
Started
2024-10-28
Last updated
2025-02-18

Condition(s) studied

Musculoskeletal Pain

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The judgment criterion is composite in order to retrospectively evaluate the relevance of the prescription, administration and monitoring of the intranasal fentanyl (FIN) protocol. — Up to 2 years
    The judgment criterion includes, 1) the prescription and 2) the administration and monitoring. 1\) Concerning the prescription: * Compliance with the contraindications of intranasal fentanyl (weight less than 10kg and/or age less than 1 year). * Compliance with the medical indication according to the protocol (pathologies and/or procedures performed and/or initial assessment of pain). * Compliance with the prescription terms (indication of the dead space, unit, route of administration and dose).
  • 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, — Up to 2 years
    The judgment criterion includes, 1) the prescription and 2) the administration and monitoring. 2\) Concerning the administration and monitoring: * Compliance with the double nursing check, product administration schedule and identification of the caregiver. * Nursing monitoring in accordance with the protocol, i.e. taking hemodynamic and respiratory constants (Sat02, FR, FC and TA) before taking fentanyl, at 10-15 minutes, at 30 minutes and at 1 hour.

Trial sites (1)

FacilityCityRegionStatus
Service d'Urgences Médico-Chirurgicales Pédiatriques - CHU de Strasbourg - France Strasbourg France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06832046 on ClinicalTrials.gov ↗ ← All trials in France