Treatment Of Fever And Associated Symptoms In The Emergency Department: Which Drug To Choose?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 324
- Locations
- 1
- Primary Endpoint
- body temperature
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
body temperature
Time Frame: 1 hour
the reduction of 1-degree of body temperature after 1 hour (T1) after the drug administration
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
- adverse events(2 hours)
- rescue therapy(2 hours)
- the reduction of at least 2 points on the Numerical Rating Scale (NRS) after two hours (T2) after the drug administration(2 hours)