Treatment Of Fever In The Emergency Department

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05814302
• Other study ID #: 3710
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Fever

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli, IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body temperature	the reduction of 1-degree of body temperature after 1 hour (T1) after the drug administration	1 hour
Primary	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	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
Secondary	rescue therapy	to identify the number of patients (%) who needed a rescue therapy	2 hours
Secondary	adverse events	to identify the percentage (%) of adverse events	2 hours