Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT03063359
Eligibility Criteria:
Inclusion Criteria:
* Patient aged between 4 years old and 15,3 years old
* Acute pain in traumatic context with a suspicion of fracture for patient \<7years old : feeling Pain \>6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not \<10 points)
* For patients \>7 years old : feeling pain \>6 points and defined thanks to a visual analogic scale
* Informed consent form signed by parents
* Beneficiary of an european health protection
Exclusion Criteria:
* Antalgic ( II or III) within 4 hours before the inclusion
* Allergic or non-indication of fentanyl
* Allergic or contraindication of morphine sulfate
* Pre existing peripheral intravenous catheter
* Traumatic brain injury
* Nasal traumatic
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
15 Years
Study:
NCT03063359
Study Brief:
Protocol Section:
NCT03063359