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

Completed

• Conditions: Femur Fracture
• Interventions: Drug: Paracetamol

• Registration Number: NCT05025228
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2020-06
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-27
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paracetamol IV	Paracetamol	Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV).
Paracetamol OR	Paracetamol	Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS; 🇮🇹 Roma, Italy