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

NCT06464146 | Recruiting Phase 3 DMC

• 2 other identifiers: APHP2110442023-506803-25
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Limb Injury

Keywords

Fentanyl; Ketamin; Limb injury; Pain; Children

Outcome Measures

Primary Outcomes (2)

• Degree of pain (M30)

  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)

  30 minutes

• Degree of pain (M30)

  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)

  30 minutes

Secondary Outcomes (29)

• Degree of pain (M15)

  15 minutes

• Degree of pain (M15)

  15 minutes

• Degree of pain (M60)

  60 minutes

• Degree of pain (M60)

  60 minutes

• Degree of pain (M90)

  90 minutes

Study Arms (3)

Morphine

ACTIVE COMPARATOR

Oral morphine (0.5mg/kg) and IN placebo

Drug: Morphine; Drug: NaCl 0,9 %

IN Fentanyl

EXPERIMENTAL

placebo of oral morphine and IN fentanyl (1.5 µg/kg)

Drug: IN fentanyl; Drug: NaCl 0,9 %

IN Ketamin

EXPERIMENTAL

placebo of oral morphine and IN ketamine (1 mg/kg)

Drug: IN ketamine; Drug: NaCl 0,9 %

Interventions

IN fentanyl DRUG

IN fentanyl (1.5 µg/kg)

IN Fentanyl

IN ketamine DRUG

IN ketamine (1 mg/kg)

IN Ketamin

NaCl 0,9 % DRUG

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

IN Fentanyl; IN Ketamin; Morphine

Morphine DRUG

oral morphine (0.5 mg / kg)

Morphine

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (5)

Ambroise Paré Hospital

Boulogne-Billancourt, 92100, France

RECRUITING

Roger Salengro Hospital

Lille, 59000, France

RECRUITING

Timone Hospital

Marseille, 13005, France

RECRUITING

Mère-Enfant Hospital

Nantes, 44000, France

RECRUITING

Hopital Necker Enfants malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Morphine; Fentanyl; Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hélène CHAPPUY, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène CHAPPUY, MD, PhD

CONTACT

+33 1 44 49 41 26; helene.chappuy@aphp.fr

Nelly BRIAND, PhD

CONTACT

0144381862; nelly.briand@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 18, 2024
• Study Start: February 26, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)