Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma
NCT ID: NCT03063359
Last Updated: 2020-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
22 participants
INTERVENTIONAL
2017-05-30
2019-03-12
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intranasal fentanyl + Oral placebo
Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.
Intranasal 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.
Oral morphine + Intranasal placebo
Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.
Oral 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.
Interventions
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Intranasal 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.
Oral 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Allergic or non-indication of fentanyl
* Allergic or contraindication of morphine sulfate
* Pre existing peripheral intravenous catheter
* Traumatic brain injury
* Nasal traumatic
4 Years
15 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Gaël GG GUYON, MD
Role: PRINCIPAL_INVESTIGATOR
Montpellier University Hospital
Locations
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University hospital of Montpellier
Montpellier, , France
Countries
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Other Identifiers
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9732
Identifier Type: -
Identifier Source: org_study_id