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Study on Pain Relief for Limb Injuries in Children: Comparing Intranasal Fentanyl, Intranasal Ketamine, and Oral Morphine in Patients Aged 2-17 Years

Verified siteRegistered 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 is focused on finding the best way to reduce pain in children aged 2 to 17 who have suffered from limb injuries, such as broken arms or legs, and are visiting the emergency department. The study will compare the effectiveness of three different pain relief treatments: intranasal Fentanyl, intranasal Ketamine, and oral Morphine. The main goal is to determine which treatment works best at reducing moderate to severe pain within 30 minutes of administration.

Participants in the study will receive one of the three treatments. Fentanyl and Ketamine will be given through the nose using a special device, while Morphine will be taken by mouth. The study will monitor the children's pain levels at various times after receiving the medication, specifically at 15, 30, 60, 90, and 120 minutes. The study will also observe any side effects, such as drowsiness, dizziness, or nausea, and assess the overall satisfaction of the children and their parents with the treatment.

The purpose of this study is to improve pain management for children with limb injuries in emergency settings. By comparing these treatments, the study aims to identify the most effective and satisfactory method for reducing pain quickly and safely. The trial is expected to continue until June 2027, with recruitment starting in June 2024.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon arrival at the emergency department, eligibility is assessed. The child must be between 2 and 17 years old, weigh between 10 kg and 100 kg, and have a suspected fracture with pain in the limb.

    The pain score is evaluated using a scale appropriate for the child's age. Consent from a parent is required.

  2. Step 2

    Initial pain assessment

    The child's pain level is measured using the Visual Analog Scale (VAS) for children 7 years and older or the Evendol scale for children under 7 years.

    A score of 60 or higher on the VAS or 7 or higher on the Evendol scale is necessary to proceed.

  3. Step 3

    Medication administration

    The child receives one of the following treatments: intranasal fentanyl at 1.5 micrograms per kilogram, intranasal ketamine at 1 milligram per kilogram, or oral morphine at 0.5 milligrams per kilogram.

    The method of administration is determined randomly.

  4. Step 4

    Pain evaluation at 30 minutes

    Thirty minutes after receiving the medication, the child's pain is reassessed.

    Success is defined as a pain score below 5 on the Evendol scale for children under 7, or 30 or below on the VAS for children 7 and older, without needing additional pain relief.

  5. Step 5

    Ongoing pain and sedation assessment

    Pain levels are monitored at 15, 60, 90, and 120 minutes after medication administration.

    Sedation is evaluated using the University of Michigan Sedation Scale at 5, 10, 15, 30, 60, 90, and 120 minutes.

  6. Step 6

    Monitoring for side effects

    Potential side effects such as drowsiness, dizziness, nausea, and others are observed and recorded.

    Any changes in vital signs are also monitored.

  7. Step 7

    Satisfaction assessment

    Upon discharge from the emergency department, satisfaction is measured for both the child (if 7 years or older) and the parents.

    A scale from 0 to 100 is used, with 0 indicating no satisfaction and 100 indicating very satisfied.

Who can join the trial?

7 criteria

  • The child must be between 2 years and 17 years and 11 months old.
  • The child's weight must be between 10 kg and 100 kg.
  • The child must have a limb injury with suspected broken bones, showing a sudden change in shape, and must be feeling pain or unable to use the injured limb.
  • The injury must have happened within the last 12 hours.
  • If the child is 7 years or older, their pain score must be 60 out of 100 or higher. If the child is younger than 7 years, their pain score must be 7 out of 15 or higher. The pain score is a way to measure how much pain the child is feeling.
  • The child must have health insurance.
  • At least one parent must have signed a form agreeing to let the child participate in the study.

Who cannot join the trial?

8 criteria

  • Patients who are not between 2 to 17 years old cannot participate.
  • Patients who do not have limb injuries cannot participate.
  • Patients who do not require urgent care cannot participate.
  • Patients who are not able to receive medication through the nose (intranasal) cannot participate.
  • Patients who have allergies to the study medications cannot participate.
  • Patients who have certain medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to provide consent or do not have a guardian to provide consent cannot participate.
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Investigated drugs

  • Fentanyl

    is a medication used to help reduce pain. In this trial, it is given through the nose, which is known as intranasal administration. This method allows the medication to work quickly to relieve moderate to severe pain in children with limb injuries.

  • Ketamine

    is another medication used for pain relief. Like fentanyl, it is administered intranasally in this trial. Ketamine is known for its ability to reduce pain and is being tested to see how effective it is compared to other pain relief options for children with limb injuries.

  • Morphine

    is a well-known pain relief medication that is given orally in this trial. It is used to help manage moderate to severe pain. The trial aims to compare the effectiveness of oral morphine with the intranasal administration of fentanyl and ketamine in children with limb injuries.

What is already known about the treatment

  • Fentanyl

    Fentanyl is administered intranasally and is currently being studied for its effectiveness in reducing pain from limb injuries in pediatric emergency settings. It is a well-established medication in medical literature, primarily used for pain management. The main therapeutic indication for fentanyl in this trial is to alleviate moderate to severe pain. At the molecular level, fentanyl works by binding to opioid receptors in the brain, altering the perception of pain. It is classified pharmacologically as an opioid analgesic.

  • Ketamine

    Ketamine is also administered intranasally and is being evaluated for its pain-relieving properties in children with limb injuries in emergency departments. It is recognized in medical literature for its use in anesthesia and pain relief. The primary therapeutic indication in this context is to reduce moderate to severe pain. Ketamine acts by blocking NMDA receptors in the brain, which helps in modulating pain perception. It is classified as a dissociative anesthetic.

  • Morphine

    Morphine is given orally and serves as a comparison in this clinical trial to assess its effectiveness against intranasal fentanyl and ketamine for pain relief in children with limb injuries. It is a well-known medication in medical literature, widely used for pain management. The main therapeutic indication is to manage moderate to severe pain. Morphine works by binding to opioid receptors in the central nervous system, altering the perception and response to pain. It is classified as an opioid analgesic.

Investigated diseases

  • Limb Injuries

    Limb injuries refer to damage or harm to the arms or legs, which can include fractures, sprains, strains, or bruises. These injuries often result from accidents, falls, or direct impacts. The severity can range from mild, such as a simple bruise, to severe, like a compound fracture. Symptoms typically include pain, swelling, bruising, and limited movement of the affected limb. As the injury progresses, there may be changes in the appearance of the limb, such as deformity or increased swelling. Recovery time varies depending on the type and severity of the injury.

  • Urgency

    Urgency in a medical context refers to a condition that requires prompt attention but is not immediately life-threatening. It often involves situations where there is a sudden onset of symptoms that cause significant discomfort or concern. This can include severe pain, difficulty breathing, or sudden changes in health status. The progression of urgency depends on the underlying cause and how quickly it is addressed. If not managed in a timely manner, the condition may worsen, leading to more serious complications. Urgency requires quick assessment and intervention to prevent further deterioration.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IVTrial ID2023-506803-25-01Protocol codeAPHP211044Estimated enrolment300 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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