Recruiting

NCT Number: NCT06832046

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Alicia SCHEFFLER, MD

SUB_INVESTIGATOR

Claire ARBITRE, MD

SUB_INVESTIGATOR

Dimitar TCHOMAKOV, MD

CONTACT

[email protected]

33 3 88 12 81 18

Dimitar TCHOMAKOV, MD

PRINCIPAL_INVESTIGATOR

François LEFEBVRE, Statician

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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 includes, 1) the prescription and 2) the administration and monitoring.
- 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,

Time frame: Up to 2 years
The judgment criterion includes, 1) the prescription and 2) the administration and monitoring.
- 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitar TCHOMAKOV, MD

CONTACT

[email protected]

33 3 88 12 81 18

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: TraumaDol

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Feb 18, 2025
Registry last updated: Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting