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

NCT ID: NCT06194383

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-22
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

Fever

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Countries

Italy

Other Identifiers

Fondazione Policlinico Univers

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ID6119

Identifier Type: -

Identifier Source: org_study_id