Clinical trial NCT06464146: Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
Official title: Pain Reduction for Limb Injuries in Pediatric Emergency Departments: A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Limb Injury
Keywords: Fentanyl
Ketamin
Limb injury
Pain
Children
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Degree of pain (M30)
timeFrame: 30 minutes
measure: Degree of pain (M30)
timeFrame: 30 minutes
Secondary outcomes:
measure: Degree of pain (M15)
timeFrame: 15 minutes
measure: Degree of pain (M15)
timeFrame: 15 minutes
measure: Degree of pain (M60)
timeFrame: 60 minutes
measure: Degree of pain (M60)
timeFrame: 60 minutes
measure: Degree of pain (M90)
timeFrame: 90 minutes
measure: Degree of pain (M90)
timeFrame: 90 minutes
measure: Degree of pain (M120)
timeFrame: 120 minutes
measure: Degree of pain (M120)
timeFrame: 120 minutes
measure: Reduction in pain (M15)
timeFrame: 15 minutes
measure: Reduction in pain (M15)
timeFrame: 15 minutes
measure: Reduction in pain (M30)
timeFrame: 30 minutes
measure: Reduction in pain (M30)
timeFrame: 30 minutes
measure: Reduction in pain (M60)
timeFrame: 60 minutes
measure: Reduction in pain (M60)
timeFrame: 60 minutes
measure: Reduction in pain (M90)
timeFrame: 90 minutes
measure: Reduction in pain (M90)
timeFrame: 90 minutes
measure: Reduction in pain (M120)
timeFrame: 120 minutes
measure: Reduction in pain (M120)
timeFrame: 120 minutes
measure: Degree of pain (M30) for comparison ketamine vs fentanyl
timeFrame: 30 minutes
measure: Degree of pain (M30) for comparison ketamine vs fentanyl
timeFrame: 30 minutes
measure: Level of sedation (M5)
timeFrame: 5 minutes
measure: Level of sedation (M10)
timeFrame: 10 minutes
measure: Level of sedation (M15)
timeFrame: 15 minutes
measure: Level of sedation (M30)
timeFrame: 30 minutes
measure: Level of sedation (M60)
timeFrame: 60 minutes
measure: Level of sedation (M90)
timeFrame: 90 minutes
measure: Level of sedation (M120)
timeFrame: 120 minutes
measure: Number of participants with Adverse events
timeFrame: From study treatment intake until ED discharge, up to 1 day
measure: Score of satisfaction
timeFrame: At ED discharge, up to 1 day
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Ambroise Paré Hospital
city: Lille
country: France
facility: Roger Salengro Hospital
city: Marseille
country: France
facility: Timone Hospital
city: Nantes
country: France
facility: Mère-Enfant Hospital
city: Paris
country: France
facility: Hopital Necker Enfants malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hélène CHAPPUY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: