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Completed

NCT Number: NCT03912090

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.

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Key information

Conditions

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

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz Thionville

Metz, Moselle, 57085, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

    SpO2

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: FENTANYLIN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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