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

• Intranasal Sufentanil (Drug): After randomization, the children will receive intranasal Sufentanil .
• Intranasal Ketamine (IN) (Drug): After randomization, chidren will receive intranasal Ketamine

Primary outcomes

• Change in pain intensity from baseline to 30 minutes after intranasal administration [30 minutes after the administration of the treatment.]: Pain intensity will be measured using a validated 100-mm Visual Analogue Scale (VAS) appropriate for children aged 6 years and older. The baseline pain score (T0) will be recorded immediately before intranasal administration of the study medication. .

Secondary outcomes

• Time to effective analgesia [every 5 minutes for the first 30 minutes]: Time in minutes from intranasal drug administration to the first reduction of at least 20 mm on the Visual Analogue Scale (VAS). Pain is assessed every 5 minutes up to 30 minutes. Observations are censored if rescue analgesia is required.
• Excessive sedation [every 5 minutes for the first 30 minutes]: Sedation assessed using the Ramsay Sedation Scale. Excessive sedation is defined as a Ramsay score greater than 3 at any time during follow-up.
• Child-reported satisfaction with pain management [at 60 minutes]: Child-reported satisfaction assessed using a smiley-face scale for children under 10 years and a validated PREM questionnaire for children aged 10 years and older.

Other outcomes

• Adverse events [every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.]: Occurrence of adverse events during follow-up, including respiratory depression, bradycardia, hypotension, and discomfort during intranasal administration.
• Parental satisfaction with pain management [at 60 minutes]: Parental satisfaction assessed at the end of follow-up using a three-option question: satisfied, not satisfied, or no opinion.
• Treatment tolerance: discomfort from intranasal instillation [every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.]: Monitoring for potential adverse events such as discomfort from intranasal instillation. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
• Treatment tolerance: Bradycardia [every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.]: Monitoring for potential adverse events such as bradycardia. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
• Treatment tolerance: Desaturation [every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.]: Monitoring for potential adverse events such as desaturation. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
• Treatment tolerance: Bradypnea [every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.]: 3 - Monitoring for potential adverse events such as bradypnea. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
• Treatment tolerance: sedation [every 5 minutes for the first 30 minutes then every 10 minutes until 60 minutes after the study treatment administration.]: Monitoring for potential adverse events such as sedation. For each adverse effect, the rate of patients experiencing at least one occurrence will be calculated, the severity will be graded, and the need for additional intervention will be documented.
• Assessment of supplemental analgesic consumption: Before Time 0 [Time 0]: Consumption of additional analgesics will be assessed as binary parameters (yes/no).
• Assessment of supplemental analgesic consumption: After Time 0 [60 minutes]: Consumption of additional analgesics will be assessed as binary parameters (yes/no).
• Assessment of supplemental analgesic consumption: Category [60 minutes]: 3 catergories will be classified: * Level I (e.g., paracetamol, ibuprofen) * Level II (e.g., profenid) * MEOPA (equimolar mixture of oxygen and nitrous oxide)
• Assessment of supplemental analgesic consumption: Administrative reason [60 minutes]: The reasons for administering additional analgesics (e.g., persistent pain, child's request, clinical assessment, immobilization) will be documented.
• Deadline of supplemental analgesic consumption [60 minutes]: The time to administration of additional analgesic, defined as the time in minutes between administration of the primary treatment (T0) and the first dose of additional analgesic, will be collected and analyzed.

Sex: All, ages: 6 Years to 17 Years

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)
* Acute traumatic lime injury
* 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
* For post-menarche girls: negative urine pregnancy test and effective contraception, in accordance with national regulations

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

• Results publication: Mendes Dos Reis C, Olla M, Freyssinet E, Baranton E, Joulie A, Fontas E, Tran A. Intranasal sufentanil versus ketamine for acute severe traumatic pain in children: protocol for a phase II randomised controlled trial (SUF-KET-PED). BMJ Open. 2026 May 20;16(5):e112617. doi: 10.1136/bmjopen-2025-112617. PMID 42161544

• MARCO OLLA, MD, Principal investigator, Fondation Lenval Hôpitaux pediatrique Nice chu Lenval

NIH grants: 2025