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

NCT06832046 | Recruiting

• 1 other identifier: 9480
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Pain

Keywords

Pain Syndrome; Intranasal Fentanyl; pediatric; Pediatric surgical emergency

Outcome Measures

Primary Outcomes (2)

• 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, 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).

  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,

  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.

  Up to 2 years

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Child \< 18 years old who has benefited from intranasal fentanyl between 08/01/2022 and 09/31/2024.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain; Somatoform Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Dimitar TCHOMAKOV, MD

CONTACT

33 3 88 12 81 18; Dimitar.tchomakov@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 18, 2025
• Study Start: October 28, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 28, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

FR (1)