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

Acute Pain Clinical Trial

— FENTANYLIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912090
• Other study ID #: 2018-07Obs-CHRMT
• Status: Completed
• Start date: October 30, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2019
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Locations

Country	Name	City	State
France	CHR Metz Thionville	Metz	Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory frequency	Respiratory frequency	Day 1
Secondary	Cardiac frequency	Cardiac frequency	Day 1
Secondary	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
Secondary	Oxygen saturation	SpO2	Day 1