Pain, Acute
Conditions
Keywords
traumatic pain, children, fentanyl, intranasal use
Brief summary
Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments. To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it. The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.
Interventions
DRUGIntranasal fentanyl + Oral Placebo
Administration of intranasal fentanyl (1.5µg/kg) and Oral placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.
DRUGOral Morphine + Intranasal Placebo
Administration of oral morphine (0,4mg/kg) and intranasal placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged between 4 years old and 15,3 years old * Acute pain in traumatic context with a suspicion of fracture for patient \<7years old : feeling Pain \>6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not \<10 points) * For patients \>7 years old : feeling pain \>6 points and defined thanks to a visual analogic scale * Informed consent form signed by parents * Beneficiary of an european health protection
Exclusion criteria
* Antalgic ( II or III) within 4 hours before the inclusion * Allergic or non-indication of fentanyl * Allergic or contraindication of morphine sulfate * Pre existing peripheral intravenous catheter * Traumatic brain injury * Nasal traumatic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the value of the pain feeling | 45 minutes | Assessment of the value of the pain feeling measured by visual analogic scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delay in treatment efficacy | up to 45 minutes | Delay in treatment efficacy measured by a reduction of pain (1 point) assessed by visual analogic scale from the administration of the treatement. |
Countries
France
Outcome results
None listed