Treatment Of Fever In The Emergency Department

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT05814302

Collaborator

(none)

324

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fever	Drug: Paracetamol

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 Design

Study Type:

Observational

Actual Enrollment :

324 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Treatment Of Fever And Associated Symptoms In The Emergency Department: Which Drug To Choose?

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

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

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".
rescue therapy [2 hours]
to identify the number of patients (%) who needed a rescue therapy
adverse events [2 hours]
to identify the percentage (%) of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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