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

Using, Efficacity and Safety of Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• France
  • Moselle
    • Metz, Moselle, France, 57085
      • CHR Metz Thionville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale evolution	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")	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory frequency	Respiratory frequency	Day 1
Cardiac frequency	Cardiac frequency	Day 1
Glasgow Coma scale	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.	Day 1
Oxygen saturation	SpO2	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: pediatric; emergency; intranasal; fentanyl
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain
• Other Study ID Numbers: 2018-07Obs-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No