Clinical trial NCT05025228: Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?
Official title: Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Fracture
Keywords: Femur Fracture
Pain
Paracetamol
Emergency Department
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with femur fracture admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

Brief summary: The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.

Detailed description: The investigators enrolled 170 consecutive patients with femur fracture and severe pain. The patients received an initial analgesic treatment with paracetamol orally (OR) or intravenously (IV). The primary outcome was the reduction of pain of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1). Secondary endpoints included the reduction of pain of at least 2 points on the VAS scale at the 4 th hour (T4), the need of rescue therapy and the number of adverse events.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
* Femur Fracture
* Patients who signed the informed consent
* Able to take analgesic therapy both orally (OR) and intravenously (IV)
* Able to define pain by VAS

Exclusion Criteria:

* Age \<18 years
* Allergy to paracetamol
* Unable to take analgesic therapy both orally (OR) and intravenously (IV)
* Unable to define pain by VAS

Primary outcomes:
measure: Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1).
timeFrame: Baseline and 1 hour
Secondary outcomes:
measure: Pain change of at least 2 points on the VAS scale at the 4 th hour (T4)
timeFrame: Baseline and 4 hours
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Francesco Franceschi
role: STUDY_DIRECTOR
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