Musculoskeletal PainTraumaDolNCT06832046
Evaluation of the "Intranasal Fentanyl" Protocol in Pediatric Surgical Emergencies at Strasbourg University Hospital
An observational study of Musculoskeletal Pain, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Musculoskeletal Pain
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2024to 28 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- Child
Study population: Child < 18 years old who has benefited from intranasal fentanyl between 08/01/2022 and 09/31/2024.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Urgences Médico-Chirurgicales Pédiatriques - CHU de Strasbourg - France
Strasbourg, 67091
Dimitar TCHOMAKOV, MD, 33 3 88 12 81 18, Dimitar.tchomakov@chru-strasbourg.fr
Dimitar TCHOMAKOV, MD
About this study
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
- Medical subject headings
- Musculoskeletal Pain, Somatoform Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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).
Measured: 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.
- 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start28 Oct 2024
- Primary completionApr 2026 (estimated)
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832046
- Sponsor's protocol ID
- 9480
- Acronym
- TraumaDol
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the "Intranasal Fentanyl" Protocol in Pediatric Surgical Emergencies at Strasbourg University Hospital
- ClinicalTrials.gov ID
- NCT06832046
- Acronym / sponsor ID
- TraumaDol / 9480
- Conditions
- Musculoskeletal Pain
- Keywords
- Pain Syndrome, Intranasal Fentanyl, pediatric, Pediatric surgical emergency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Child < 18 years old who has benefited from intranasal fentanyl between 08/01/2022 and 09/31/2024.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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. 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,
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitar TCHOMAKOV, MD (33 3 88 12 81 18, Dimitar.tchomakov@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.