Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05025228

Enrollment

170

Registered

2021-08-27

Start date

2019-06-01

Completion date

2020-06-30

Last updated

2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Fracture

Keywords

Femur Fracture, Pain, Paracetamol, Emergency Department

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.

Interventions

DRUGParacetamol

Paracetamol given orally or intravenously

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1).	Baseline and 1 hour	The Visual Analogue Scale for Pain (VAS) is a validated self-reported instrument that identifies pain from 0 to 10 (with 0 = no pain and 10 = maximum pain intensity)

Secondary

Measure	Time frame	Description
Pain change of at least 2 points on the VAS scale at the 4 th hour (T4)	Baseline and 4 hours	identifies pain from 0 to 10 (with 0 = no pain and 10 = maximum pain intensity)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026