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

University Hospital Center (CHU)

Status and phase: Terminated; Phase 3

Conditions: Pain, Acute

Treatments: Drug: Intranasal fentanyl + Oral Placebo; Drug: Oral Morphine + Intranasal Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03063359

9732

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 4 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Intranasal fentanyl + Oral placebo

Experimental group

Description:

Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.

Treatment:

Drug: Intranasal fentanyl + Oral Placebo

Oral morphine + Intranasal placebo

Active Comparator group

Description:

Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.

Treatment:

Drug: Oral Morphine + Intranasal Placebo