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NCT Number: NCT06464146

Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine

The purpose of this study is to determine if IN fentanyl (1.5 µg/kg) or IN ketamine (1 mg/kg) is more effective at 30 minutes than oral morphine (0.5 mg/kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ambroise Paré Hospital, Boulogne-Billancourt, France

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About this study

In children with moderate to severe pain due to musculoskeletal injuries, the first-line analgesic therapy in pediatric emergency departments (ED) is oral or intravenous morphine. Due to the delay or discomfort associated with establishing IV access, oral forms are preferred in French ED. Unfortunately, oral morphine alone or with ibuprofen or paracetamol, none regimen is optimal for relieving pain in children with traumatic limb injuries. However, the use of intranasal course is a safe route that can provide rapid and almost immediate analgesia. Intranasal administration is easy, non-invasive and usually well tolerated by children. In the last years, drugs with analgesic and sedative properties is increasing, particularly on fentanyl, ketamine, which can be also administered by the IN route. There are currently no studies, neither published nor ongoing, which compare IN fentanyl or IN ketamine to a standard oral morphine for children with acute moderate to severe pain with limb injuries presenting to the ED. The main hypothesis is that the efficacy of the analgesia 30 minutes after the administration will be higher with IN Fentanyl or with IN Ketamine, when compared to oral morphine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child aged 2 years to 17 years and 11 months
  • With 10 kg ≤ Weight ≤ 100 kg
  • Presenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and/or functional impotence in the injured limb(s)
  • Within the first 12 hours after the injury
  • VAS pain score at ED arrival ≥ 60/100 (if child ≥ 7 years) or Evendol pain score at ED arrival ≥ 7/15 (if child < 7 years)
  • Affiliated to health insurance
  • At least one signed parental informed consent

Exclusion criteria

  • Received narcotic pain medication prior to arrival
  • Contraindication to morphine, mentioned in SmPC
  • Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids.
  • Contraindication to fentanyl or ketamine, mentioned in SmPC
  • GCS <15
  • Evidence of significant femur, head, chest, abdominal, or spine injury
  • Open fracture
  • Nasal trauma or complete nasal obstruction
  • Active epistaxis
  • Nasal or sinus surgery within 6 months before inclusion
  • History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, major psychiatric disorder, hepatocellular insufficiency
  • Active or history of psychiatric disorder
  • Known pregnancy or suspicion of being pregnant
  • Breastfeeding
  • Non-French speaking parent and / or child.
  • Participation to another interventional clinical research

Treatment and study plan

Morphine

Drug

oral morphine (0.5 mg / kg)

IN fentanyl

Drug

IN fentanyl (1.5 µg/kg)

IN ketamine

Drug

IN ketamine (1 mg/kg)

NaCl 0,9 %

Drug

Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.

Primary outcomes

  1. Degree of pain (M30)

    Time frame: 30 minutes

    Success: children <7 years with a pain score assessed by Evendol < 5 years, 30 minutes after drugs administration, without rescue analgesia. Scale: 0-15 (no pain - painful)

  2. Degree of pain (M30)

    Time frame: 30 minutes

    Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia. Visual Analog Scale : 0-100 (no pain- painful)

Secondary outcomes

  1. Degree of pain (M15)

    Time frame: 15 minutes

    Success: children <7 years with a pain score assessed by Evendol < 5, 15 minutes after drugs administration, without rescue analgesia

  2. Degree of pain (M15)

    Time frame: 15 minutes

    Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 15 minutes after drugs administration, without rescue analgesia

  3. Degree of pain (M60)

    Time frame: 60 minutes

    Success: children <7 years with a pain score assessed by Evendol < 5, 60 minutes after drugs administration, without rescue analgesia

  4. Degree of pain (M60)

    Time frame: 60 minutes

    Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 60 minutes after drugs administration, without rescue analgesia

  5. Degree of pain (M90)

    Time frame: 90 minutes

    Success: children <7 years with a pain score assessed by Evendol < 5, 90 minutes after drugs administration, without rescue analgesia

  6. Degree of pain (M90)

    Time frame: 90 minutes

    Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 90 minutes after drugs administration, without rescue analgesia

  7. Degree of pain (M120)

    Time frame: 120 minutes

    Success: children <7 years with a pain score assessed by Evendol < 5, 120 minutes after drugs administration, without rescue analgesia

  8. Degree of pain (M120)

    Time frame: 120 minutes

    Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 120 minutes after drugs administration, without rescue analgesia

  9. Reduction in pain (M15)

    Time frame: 15 minutes

    Reduction in pain from baseline assessed by Evendol for children <7 years

  10. Reduction in pain (M15)

    Time frame: 15 minutes

    Reduction in pain from baseline assessed by VAS for children ≥ 7 years

  11. Reduction in pain (M30)

    Time frame: 30 minutes

    Reduction in pain from baseline assessed by Evendol for children <7 years

  12. Reduction in pain (M30)

    Time frame: 30 minutes

    Reduction in pain from baseline assessed by VAS for children ≥ 7 years

  13. Reduction in pain (M60)

    Time frame: 60 minutes

    Reduction in pain from baseline assessed by Evendol for children <7 years

  14. Reduction in pain (M60)

    Time frame: 60 minutes

    Reduction in pain from baseline assessed by VAS for children ≥ 7 years

  15. Reduction in pain (M90)

    Time frame: 90 minutes

    Reduction in pain from baseline (assessed by VAS for children ≥ 7 years)

  16. Reduction in pain (M90)

    Time frame: 90 minutes

    Reduction in pain from baseline assessed by Evendol for children <7 years

  17. Reduction in pain (M120)

    Time frame: 120 minutes

    Reduction in pain from baseline assessed by VAS for children ≥ 7 years

  18. Reduction in pain (M120)

    Time frame: 120 minutes

    Reduction in pain from baseline assessed by EVENDOL for children < 7 years

  19. Degree of pain (M30) for comparison ketamine vs fentanyl

    Time frame: 30 minutes

    Success pain evaluation, as defined in primary outcome (for the comparison between ketamine and fentanyl) assessed by Evendol for children <7 years

  20. Degree of pain (M30) for comparison ketamine vs fentanyl

    Time frame: 30 minutes

    Success pain evaluation, as defined in primary outcome (for the comparison between ketamine and fentanyl) assessed by VAS for children ≥ 7 years

  21. Level of sedation (M5)

    Time frame: 5 minutes

    Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable)

  22. Level of sedation (M10)

    Time frame: 10 minutes

    Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable)

  23. Level of sedation (M15)

    Time frame: 15 minutes

    Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable)

  24. Level of sedation (M30)

    Time frame: 30 minutes

    Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable)

  25. Level of sedation (M60)

    Time frame: 60 minutes

    Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable)

  26. Level of sedation (M90)

    Time frame: 90 minutes

    Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable)

  27. Level of sedation (M120)

    Time frame: 120 minutes

    Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable)

  28. Number of participants with Adverse events

    Time frame: From study treatment intake until ED discharge, up to 1 day

    Adverse events potentially associated with IN ketamine, IN fentanyl and/or oral morphine: drowsiness, dizziness, pruritus, nausea, vomiting, dysphoria, nasal burning and irritation, unpleasant taste, vision changes, throat irritation, headache, vital sign changes (heart rate, respiratory rate, oxygen saturation, blood pressure).

  29. Score of satisfaction

    Time frame: At ED discharge, up to 1 day

    General satisfaction of parents and patient ≥ 7 years old on a scale of 0-100 with corresponding faces (0 = no satisfaction at all, 100 = very satisfied)

Study contacts

Contact information is provided by the study sponsor or research team.

Hélène CHAPPUY, MD, PhD

CONTACT

[email protected]

+33 1 44 49 41 26

Nelly BRIAND, PhD

CONTACT

[email protected]

0144381862

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Pain Reduction for Limb Injuries in Pediatric Emergency Departments: A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine

Acronym: ANTAMIN

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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