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

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. .

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.

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 assessed using a smiley-face scale for children under 10 years and a validated PREM questionnaire for children aged 10 years and older.

Occurrence of adverse events during follow-up, including respiratory depression, bradycardia, hypotension, and discomfort during intranasal administration.

Parental satisfaction assessed at the end of follow-up using a three-option question: satisfied, not satisfied, or no opinion.

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.

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.

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.

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.

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.

Consumption of additional analgesics will be assessed as binary parameters (yes/no).

Consumption of additional analgesics will be assessed as binary parameters (yes/no).

3 catergories will be classified:

• Level I (e.g., paracetamol, ibuprofen)
• Level II (e.g., profenid)
• MEOPA (equimolar mixture of oxygen and nitrous oxide)

The reasons for administering additional analgesics (e.g., persistent pain, child's request, clinical assessment, immobilization) will be documented.

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.