Treatment Of Fever In The Emergency Department

Completed

• Conditions: Fever

• Registration Number: NCT05814302
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Fever is a frequent cause of admission to the Emergency Department (ED) around the world. While it can be caused by a wide range of conditions, the most effective treatment based on its etiology is still undetermined. This observational, prospective, single-center study enrolled adult patients who accessed the ED for fever, with the aim to define the most effective treatment for them.

Detailed Description

Physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I).The primary endpoint was both 1-degree and 1-point reduction in body temperature for all associated symptoms on the Numeric Rating Scale (NRS) after 1 hour (T1). Secondary endpoint was the reduction of at least 2 points on the NRS after two hours (T2). Adverse events, the needing of a rescue therapy and the response based on the underlying etiology (bacterial, viral, or immune/neoplastic) were also evaluated.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• fever with/without associated symptoms
• adults who had given their consent to participate in the study.

Exclusion Criteria

• age < 18 years old
• contraindications or allergies to Paracetamol, Ibuprofen or to the combination Paracetamol/Ibuprofen
• patients unable to take oral drugs
• patients who did not express their consent to participate to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
body temperature	1 hour	the reduction of 1-degree of body temperature after 1 hour (T1) after the drug administration
Numerical Rating Scale (NRS)	1 hour	the reduction of 1-point for all associated symptoms on NRS after 1 hour (T1) after the drug administration. NRS is a "0-10" scale tool to assess pain severity, with zero that means "no pain" and 10 "the worst pain".

Secondary Outcome Measures

Name	Time	Method
adverse events	2 hours	to identify the percentage (%) of adverse events
rescue therapy	2 hours	to identify the number of patients (%) who needed a rescue therapy
the reduction of at least 2 points on the Numerical Rating Scale (NRS) after two hours (T2) after the drug administration	2 hours	the secondary endpoint was to evaluate the number of patients (%) who obtained a reduction of at least 2 points on the NRS scale, in at least one of the symptoms associated with fever 2 hours after the antypiretic administration (T2). NRS is a "0-10" scale tool to assess pain severity, with zero that means "no pain" and 10 "the worst pain".

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS; 🇮🇹 Roma, Italy