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

NCT ID: NCT06464146

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2028-02-29

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.

Detailed Description

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.

Conditions

Limb Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Morphine

Oral morphine (0.5mg/kg) and IN placebo

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

oral morphine (0.5 mg / kg)

NaCl 0,9 %

Intervention Type: DRUG

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

IN Fentanyl

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

Group Type: EXPERIMENTAL

IN fentanyl

Intervention Type: DRUG

IN fentanyl (1.5 µg/kg)

NaCl 0,9 %

Intervention Type: DRUG

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

IN Ketamin

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

Group Type: EXPERIMENTAL

IN ketamine

Intervention Type: DRUG

IN ketamine (1 mg/kg)

NaCl 0,9 %

Intervention Type: DRUG

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

Interventions

Morphine

oral morphine (0.5 mg / kg)

Intervention Type: DRUG

IN fentanyl

IN fentanyl (1.5 µg/kg)

Intervention Type: DRUG

IN ketamine

IN ketamine (1 mg/kg)

Intervention Type: DRUG

NaCl 0,9 %

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélène CHAPPUY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Ambroise Paré Hospital

Boulogne-Billancourt, , France

Site Status: RECRUITING

Roger Salengro Hospital

Lille, , France

Site Status: RECRUITING

Timone Hospital

Marseille, , France

Site Status: RECRUITING

Mère-Enfant Hospital

Nantes, , France

Site Status: RECRUITING

Hopital Necker Enfants malades

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Hélène CHAPPUY, MD, PhD

Role: CONTACT

helene.chappuy@aphp.fr

+33 1 44 49 41 26

Nelly BRIAND, PhD

Role: CONTACT

nelly.briand@aphp.fr

0144381862

Facility Contacts

Marlène MICHELON JOUNEAUX, MD, PhD

Role: primary

marlene.michelonjouneaux@aphp.fr

01 49 09 57 00

Melany LIBER, MD, PhD

Role: primary

melany.liber@chu-lille.fr

03 20 44 46 64 ext. +33

Aurélie MORAND, MD, PHD

Role: primary

aurelie.morand@ap-hm.fr

04 91 38 96 99 ext. +33

Adeline BOUCHERON

Role: primary

adeline.boucheron@chu-lille.fr

02 44 76 84 79 ext. +33

Hélène CHAPPUY, MD, PhD

Role: primary

helene.chappuy@aphp.fr

+33 1 44 49 41 26 ext. +33

Other Identifiers

2023-506803-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APHP211044

Identifier Type: -

Identifier Source: org_study_id