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

NCT03912090 | Completed

• 1 other identifier: 2018-07Obs-CHRMT
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

pediatric; fentanyl; intranasal; emergency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Respiratory frequency

  Day 1

• Cardiac frequency

  Day 1

• Glasgow Coma scale

  Day 1

• Oxygen saturation

  Day 1

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz Thionville

Metz, Moselle, 57085, France

Location

MeSH Terms

Conditions

Acute Pain; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: October 30, 2018
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)