Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Morphine, IN fentanyl, IN ketamine, NaCl 0,9 %.
- Who it may be relevant to
- Registry conditions: Limb Injury. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine
Overview
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.
Interventions
- Drug Morphine
oral morphine (0.5 mg / kg) - Drug IN fentanyl
IN fentanyl (1.5 µg/kg) - Drug IN ketamine
IN ketamine (1 mg/kg) - Drug NaCl 0,9 %
Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.
Primary outcome measures
- Degree of pain (M30) [Time frame: 30 minutes]
- Degree of pain (M30) [Time frame: 30 minutes]
Secondary outcome measures (12)
- Degree of pain (M15) [Time frame: 15 minutes]
- Degree of pain (M15) [Time frame: 15 minutes]
- Degree of pain (M60) [Time frame: 60 minutes]
- Degree of pain (M60) [Time frame: 60 minutes]
- Degree of pain (M90) [Time frame: 90 minutes]
- Degree of pain (M90) [Time frame: 90 minutes]
- Degree of pain (M120) [Time frame: 120 minutes]
- Degree of pain (M120) [Time frame: 120 minutes]
- Reduction in pain (M15) [Time frame: 15 minutes]
- Reduction in pain (M15) [Time frame: 15 minutes]
- Reduction in pain (M30) [Time frame: 30 minutes]
- Reduction in pain (M30) [Time frame: 30 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 5 centers
- Ambroise Paré Hospital — Boulogne-Billancourt
- Roger Salengro Hospital — Lille
- Timone Hospital — Marseille
- Mère-Enfant Hospital — Nantes
- Hopital Necker Enfants malades — Paris
Identifiers
NCT: NCT06464146 · APHP211044 · 2023-506803-25