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

NCT06194383 | Unknown

• 2 other identifiers: ID6119Fondazione Policlinico Univers
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Response to the treatment as evaluation of associated symptoms

  Evaluation of associated symptoms by pain scale

  1 hour

Eligibility Criteria

• Age: 6 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: December 22, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 8, 2024

Record last verified: 2023-12

Locations

IT (1)