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Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital. (FENTANYLIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03912090
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : May 14, 2019
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Brief Summary:
The treatment of acute severe pain in pediatric emergencies required a quick and effective therapeutic support. Actually in France, only peripheral venous access or oral therapies with onset of action are commonly used and only few treatments can be used to manage the acute severe pain in children. In June 2017, an intranasal fentanyl use protocol has been established in the pediatric emergency department of Mercy hospital-Metz. The intranasal fentanyl treatment has proved his effectiveness and safe condition in many countries since few years even though has not yet obtained a marketing authorization for use in children in France. In view of the information, parental permission was obtained before the intranasal administration. The efficacy and surveillance data in all patient records of children who benefited this analgesic protocol were retrospectively collected between June 2017 and August 2018. This retrospective study wants to describe the efficacy and safety of intranasal fentanyl on the pediatric emergency department.

Condition or disease
Acute Pain

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Using, Efficacity and Safety of Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pain scale evolution [ Time Frame: Day 1 ]

    Face Legs Activity Cry Consolability (FLACC) scale or Visual Analog Scale (VAS) FLACC scale involve, as its name implies, 5 items: face, legs, activity, cry and consolability with a score ranging from 0 to 2 each, knowing that 0 represents "no pain". The sum of each items is from 0 to 10, and 10 constitutes an intense pain.

    VAS is a 100-mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling. Patients should mark the point on the line that the best correspond to their symptom severity. The patient's mark indicates pain severity and it's quantified by measuring the distance in millimeter from 0 (0 representes "no pain" and 100 represents "worst possible pain")

Secondary Outcome Measures :
  1. Respiratory frequency [ Time Frame: Day 1 ]
    Respiratory frequency

  2. Cardiac frequency [ Time Frame: Day 1 ]
    Cardiac frequency

  3. Glasgow Coma scale [ Time Frame: Day 1 ]
    The Glasgow Coma scale (GCS) describes the level of consciousness. The GCS measures 3 functions: eye opening (with score between 1 and 4), verbal response (with score between 1 and 5) and motor response (with score between 1 and 6). Then, the sum of the scores is calculated. Pediatric brain injury are classified by severity 8 or lower reflecting the most severe, 9-12 being a moderate injury and 13-15 indicating a mild traumatic brain injury.

  4. Oxygen saturation [ Time Frame: Day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Pediatric patients of the emergency pediatric department of Mercy hospital
  • Coming for acute severe pain : EVA or FLACC scale >=6 for less than 6 hours
  • Age more than 12months
  • Weight 10kg to 68kg
  • Veinous access difficult to obtain
  • No contra-indication for fentanyl use
  • No contra-indication for intranasal administration

Inclusion Criteria:

  • All patients who received fentanyl intranasal between june 2017 and august 2018

Exclusion Criteria:

  • Lack of surveillance data in the medical record of the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03912090

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CHR Metz Thionville
Metz, Moselle, France, 57085
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville

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Responsible Party: Centre Hospitalier Régional Metz-Thionville Identifier: NCT03912090     History of Changes
Other Study ID Numbers: 2018-07Obs-CHRMT
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional Metz-Thionville:
Additional relevant MeSH terms:
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Acute Pain
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General