Status:
NOT_YET_RECRUITING
Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.
Lead Sponsor:
Fondation Lenval
Conditions:
Traumatology
Wounds and Injury
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
This study aims to compare two treatments for managing severe pain in children who have suffered trauma and are treated in pediatric emergency departments. Specifically, it evaluates intranasal sufent...
Eligibility Criteria
Inclusion
- Children aged 6 to 17 years inclusive, under 18 years old, weighing more than 10kg, and requiring analgesia for the management of acute pain
- Presenting with pain assessed as severe using a validated pain scale (VAS ≥ 6/10)
- Pain caused by trauma, excluding thoracic trauma with dyspnea and abdominal pain
- Obtaining written and signe informed consent from one of the two parents or legal guardians
- Affiliation with a social security system
- Hemodynamically stable
Exclusion
- Patient in a state of immediate life-threatening distress
- Parents who don't understand and/or don't speak French
- Known hypersensitivity to opiods
- Allergy to one of the study treatments
- History of epilepsy or known psychiatric illness
- History of respiratory, cardiac or renal insufficiency
- Use of serotonergic antidepressants
- Any child with an ongoing respiratory condition (asthma, laryngitis)
- Thoracic trauma
- Use of opioids within the 4 hours prior to arrival in the ermergency department
- Any child with an ongoing respiratory condition (asthma, laryngitis)
- Thoracic trauma
- Use of opioids within the 4 hours prior to arrival in the ermergency department
- History of head, abdominal, or spinal trauma
- Confirmed pregnancy
- History of toxic substance use
- Facial or nasal trauma
- Whithdrawal of informed consent from the parents or legal guardian
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06968546
Start Date
September 1 2025
End Date
March 31 2028
Last Update
May 13 2025
Active Locations (1)
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1
Hôpital lenval
Nice, France, France, 06000