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

Fever Clinical Trial

— FEVER_ED  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06194383
• Other study ID #: ID6119
• Secondary ID: Fondazione Polic
• Status: Active, not recruiting
• Start date: December 22, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Fever
• Hyperthermia

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to the treatment as evaluation of associated symptoms	Evaluation of associated symptoms by pain scale	1 hour