Treatment Of Fever In The Emergency Department

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

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.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 324

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults > 18 years old with fever and associated symptoms accessing the ED

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body temperature	the reduction of 1-degree of body temperature after 1 hour (T1) after the drug administration	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".	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	2 hours
rescue therapy	to identify the number of patients (%) who needed a rescue therapy	2 hours
adverse events	to identify the percentage (%) of adverse events	2 hours

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department; Fever; Paracetamol; Paracetamol/Ibuprofen
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Body Temperature Changes; Emergencies; Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 3710

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No