Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma

Pain, Acute Clinical Trial

— FINDOL  

Official title:

Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03063359
• Other study ID #: 9732
• Status: Terminated
• Phase: Phase 3
• Start date: May 30, 2017
• Est. completion date: March 12, 2019

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: March 12, 2019
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the value of the pain feeling	Assessment of the value of the pain feeling measured by visual analogic scale	45 minutes
Secondary	Delay in treatment efficacy	Delay in treatment efficacy measured by a reduction of pain (1 point) assessed by visual analogic scale from the administration of the treatement.	up to 45 minutes