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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06832046

Acronym

TraumaDol

Enrollment

500

Registered

2025-02-18

Start date

2024-10-28

Completion date

2026-04-28

Last updated

2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Pain

Keywords

Pain Syndrome, Intranasal Fentanyl, pediatric, Pediatric surgical emergency

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Contacts

Primary ContactDimitar TCHOMAKOV, MD

Dimitar.tchomakov@chru-strasbourg.fr33 3 88 12 81 18

Outcome results