Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine Vs Oral Morphine
- Conditions
- Limb Injury
- Interventions
- Registration Number
- NCT06464146
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Morphine Morphine Oral morphine (0.5mg/kg) and IN placebo Morphine NaCl 0,9 % Oral morphine (0.5mg/kg) and IN placebo IN Fentanyl IN fentanyl placebo of oral morphine and IN fentanyl (1.5 µg/kg) IN Fentanyl NaCl 0,9 % placebo of oral morphine and IN fentanyl (1.5 µg/kg) IN Ketamin IN ketamine placebo of oral morphine and IN ketamine (1 mg/kg) IN Ketamin NaCl 0,9 % placebo of oral morphine and IN ketamine (1 mg/kg)
- Primary Outcome Measures
Name Time Method Degree of pain (M30) 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 Outcome Measures
Name Time Method Degree of pain (M15) 15 minutes Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 15 minutes after drugs administration, without rescue analgesia
Degree of pain (M60) 60 minutes Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 60 minutes after drugs administration, without rescue analgesia
Degree of pain (M90) 90 minutes Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 90 minutes after drugs administration, without rescue analgesia
Reduction in pain (M15) 15 minutes Reduction in pain from baseline assessed by VAS for children ≥ 7 years
Degree of pain (M120) 120 minutes Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 120 minutes after drugs administration, without rescue analgesia
Reduction in pain (M30) 30 minutes Reduction in pain from baseline assessed by VAS for children ≥ 7 years
Reduction in pain (M60) 60 minutes Reduction in pain from baseline assessed by VAS for children ≥ 7 years
Reduction in pain (M120) 120 minutes Reduction in pain from baseline assessed by EVENDOL for children \< 7 years
Score of satisfaction 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)
Reduction in pain (M90) 90 minutes Reduction in pain from baseline assessed by Evendol for children \<7 years
Degree of pain (M30) for comparison ketamine vs fentanyl 30 minutes Success pain evaluation, as defined in primary outcome (for the comparison between ketamine and fentanyl) assessed by VAS for children ≥ 7 years
Level of sedation (M5) 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)
Level of sedation (M10) 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)
Level of sedation (M90) 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)
Level of sedation (M15) 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)
Level of sedation (M30) 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)
Level of sedation (M60) 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)
Level of sedation (M120) 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)
Number of participants with Adverse events 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).
Trial Locations
- Locations (5)
Ambroise Paré Hospital
🇫🇷Boulogne Billancourt, France
Roger Salengro Hospital
🇫🇷Lille, France
Timone Hospital
🇫🇷Marseille, France
Mère-Enfant Hospital
🇫🇷Nantes, France
Hopital Necker Enfants malades
🇫🇷Paris, France