Treatment Of Fever In The Emergency Department

Fondazione Policlinico Universitario Agostino Gemelli IRCCS324 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

324

Conditions

Fever

Interventions

ParacetamolDRUG

Emergency physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, Italy

Outcomes

Primary Outcomes

body temperature

the reduction of 1-degree of body temperature after 1 hour (T1) after the drug administration

Time frame: 1 hour

Numerical Rating Scale (NRS)

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".

Time frame: 1 hour

Secondary Outcomes

the reduction of at least 2 points on the Numerical Rating Scale (NRS) after two hours (T2) after the drug administration

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".

Time frame: 2 hours

rescue therapy

to identify the number of patients (%) who needed a rescue therapy

Time frame: 2 hours

adverse events

to identify the percentage (%) of adverse events

Time frame: 2 hours

Data from ClinicalTrials.gov

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