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Completed

NCT Number: NCT05814302

Treatment Of Fever In The Emergency Department

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.

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Key information

Conditions

Fever Body Temperature Changes Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

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

Other names: Combination of paracetamol/ibuprofen

Primary outcomes

  1. body temperature

    Time frame: 1 hour

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

  2. Numerical Rating Scale (NRS)

    Time frame: 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 outcomes

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

    Time frame: 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".

  2. rescue therapy

    Time frame: 2 hours

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

  3. adverse events

    Time frame: 2 hours

    to identify the percentage (%) of adverse events

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2023
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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