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Comparing intranasal sufentanil and ketamine for severe acute trauma-related pain management in children admitted to pediatric emergency care

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating severe acute trauma-related pain in children who have suffered limb injuries. The study compares two pain medications: sufentanil and ketamine, both given as nasal sprays. These medications are typically used in hospitals to manage severe pain, but in this study, they will be administered through the nose instead of traditional injection methods.

The main purpose is to determine which of these two medications works better for pain relief in children who come to the emergency department with severe limb injuries such as suspected fractures, severe sprains, dislocations, or joint trauma. The medications will be given as a single dose through a nasal spray, and pain levels will be monitored for up to 30 minutes after administration.

During the study, children will receive either intranasal sufentanil or intranasal ketamine. Other pain relief options like EMLA cream (a numbing cream), naloxone (a medication that reverses opioid effects), and Entonox (a mixture of nitrous oxide and oxygen for pain relief) will be available if needed. The children's pain levels, drowsiness, and any side effects will be monitored regularly throughout the treatment period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial pain assessment

    Your pain level will be measured using a vertical visual scale from 0 to 10

    To participate, your pain score must be greater than 6 out of 10

    The pain must be related to limb injury (arms or legs)

  2. Step 2

    Treatment administration

    You will receive one of two pain medications through nasal spray:

    Either sufentanil or ketamine will be given

    The choice of medication is determined randomly

  3. Step 3

    Regular pain monitoring

    Your pain will be checked every 5 minutes for the first 30 minutes

    A measurement of how alert you are will be taken every 5 minutes for 30 minutes

    After 30 minutes, alertness checks will continue every 10 minutes until one hour has passed

  4. Step 4

    Additional pain relief

    If needed, additional pain relief may be provided

    Different types of pain relief are available depending on your needs

  5. Step 5

    Final evaluation

    After 60 minutes, you will be asked to complete a satisfaction questionnaire

    If you are under 10 years old, you will use a form with smiley faces

    If you are over 10 years old, you will complete a 25-question form about your experience

    Your parent or guardian will also be asked about their satisfaction with your pain management

  6. Step 6

    Side effect monitoring

    Throughout the entire process, any side effects will be recorded

    Medical staff will monitor your condition continuously

Who can join the trial?

14 criteria

  • Child must be between 6 and 17 years old
  • Child must weigh more than 15 kg
  • Must have pain from limb injury (arms or legs) such as:
    • Possible broken bone
    • Severe sprains or bruises
    • Dislocated joints
    • Other joint injuries
    • Must have severe pain (pain score greater than 6 out of 10)
    • Must have stable heart rate and blood pressure
    • Must have injuries only to arms or legs
    • Must be enrolled in social security system
    • Must have consent from at least one parent or legal guardian
    • For girls who have started menstruation:
      • Must have a negative pregnancy test
      • Must be using effective birth control (pills, implant, IUD) or practicing abstinence
      • Must participate in a private discussion about contraception and pregnancy testing

Who cannot join the trial?

14 criteria

  • Children younger than 3 years or older than 17 years of age
  • Known allergy or sensitivity to any of the study medications (sufentanil or ketamine)
  • Head trauma or injury that could affect consciousness
  • Severe breathing problems or respiratory distress
  • Blocked or injured nose that would prevent nasal medication delivery
  • Current use of strong pain medications (opioids) within the past 24 hours
  • History of seizures (sudden, uncontrolled electrical disturbances in the brain)
  • Significant heart problems or abnormal heart rhythm
  • Children who cannot rate their pain using standard pain scales
  • Previous adverse reactions to pain medications
  • Active bleeding that is not controlled
  • Children with decreased level of consciousness or confusion
  • Parents/guardians unable to provide informed consent
  • Participation in another clinical trial within the past 30 days
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Investigated drugs

  • Sufentanil

    is a strong pain-relieving medication that belongs to the opioid family. When given through the nose (intranasally), it works quickly to reduce severe pain. In this trial, it is being studied for managing severe pain in children who come to the emergency department with limb injuries.

  • Ketamine

    is a medication that can provide both pain relief and sedation. When administered through the nose, it helps reduce severe pain. It has been used for many years in emergency medicine and is known for its effectiveness in managing trauma-related pain. In this trial, it is being compared to sufentanil for treating severe pain in children with limb injuries.

What is already known about the treatment

  • Sufentanil

    A potent synthetic opioid pain medication administered intranasally in this trial for acute trauma-related pain management in children. This fast-acting analgesic works by binding to mu-opioid receptors in the central nervous system, effectively blocking pain signals. Sufentanil belongs to the class of opioid analgesics and is primarily used in medical settings for severe pain management, with its intranasal formulation offering a non-invasive delivery method.

  • Ketamine

    A rapid-acting anesthetic and pain relief medication administered intranasally in this trial for treating severe acute trauma pain in pediatric patients. It works through a unique mechanism by blocking NMDA receptors in the brain, providing both pain relief and mild sedation. Ketamine belongs to the dissociative anesthetic class and has gained recognition in emergency medicine for its effectiveness in pain management, particularly when traditional opioids may not be preferred.

Investigated diseases

Severe Acute Trauma-related Pain - A condition that occurs immediately following physical injury or trauma to the body, particularly affecting limbs. It is characterized by intense, sharp pain that develops suddenly at the site of injury. The pain results from tissue damage and the activation of pain receptors in the affected area. This type of pain typically appears immediately after the traumatic event and can vary in intensity depending on the severity of the injury. The condition can affect both children and adults, causing significant discomfort and limiting normal movement and function of the affected body part.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2025-521075-31-00Protocol code24-HPNCL-03Estimated enrolment116 patientsSponsorFondation Lenval Nice

sourced from the EU Clinical Trials Register and site verification

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