Fever
Conditions
Keywords
Fever, Paracetamol, Paracetamol/Ibuprofen, Emergency Department
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.
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.
Interventions
DRUGParacetamol
Emergency physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I)
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed