Treatment of Hyperpyrexia and in the Pediatric Emergency Department (FEVER_ED) (FEVER_ED)

Optimization of the Treatment of Hyperpyrexia and Associated Symptoms in the Pediatric Emergency Department (FEVER_ED)

Fever represents the main cause of admission to the emergency room in older people pediatric. It occurs in the presence of a wide range of pathologies, from infectious forms (the most common, viral or bacterial) up to more complex and/or systemic forms (such as inflammatory or neoplastic ones). The drugs currently indicated for the management of fever in children are: paracetamol and ibuprofen. There are no recent studies conducted in pediatric population, who have demonstrated the greater effectiveness of therapy with paracetamol or ibuprofen, The objective of our study is, therefore, to identify which therapy is most appropriate for controlling body temperature e of associated symptoms in pediatric patients arriving in the emergency room with fever.

Study Overview

• Status: Active, not recruiting
• Conditions: Fever

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pediatric patients (aged between 6 months 0 and 20 years), with fever (T > 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)

Description

Inclusion Criteria:

• Pediatric patients (aged between 6 months 0 and 20 years)
• fever (T > 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)
• who have expressed their consent to participate in the study.

Exclusion Criteria:

• age <6 months or >20 years;
• patients who did not express consent to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to the treatment as evaluation of associated symptoms	Evaluation of associated symptoms by pain scale	1 hour

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Body Temperature Changes; Heat Stress Disorders; Emergencies; Hyperthermia; Fever
• Other Study ID Numbers: ID6119; Fondazione Policlinico Univers (Other Grant/Funding Number: Fondazione Policlinico Universitario A. Gemelli IRCCS)

Drug and device information, study documents

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