Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.

Launched by FONDATION LENVAL · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments to help manage severe pain in children who have experienced traumatic injuries, such as fractures or wounds, when they come to the emergency department. The trial compares a new treatment called intranasal sufentanil with an existing treatment called intranasal ketamine. Researchers want to find out if sufentanil is just as effective as ketamine in reducing pain, specifically aiming to lower pain scores by at least two points on a scale from 0 to 10.

To participate in this study, children aged 6 to 17 years who weigh more than 10 kg and are experiencing severe pain (6/10 or higher) due to trauma may be eligible. Parents or legal guardians will need to give consent for their child to join the trial. If chosen to participate, children will receive one of the two treatments when they arrive at the emergency department, and their pain relief will be monitored for one hour. This trial is important because effective pain management is crucial for children in emergency situations, and the results may help improve pain relief options available in these settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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