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

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

Detailed Description
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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.

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

Conditions
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Femur Fracture

Intervention / Treatment
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* Drug: Paracetamol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paracetamol IV<br>Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV). | Drug: Paracetamol<br>* Paracetamol given orally or intravenously<br>* Other names: N-acetyl-para-aminophenol;|
| Paracetamol OR<br>Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR). | Drug: Paracetamol<br>* Paracetamol given orally or intravenously<br>* Other names: N-acetyl-para-aminophenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1). | 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) | Baseline and 1 hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femur Fracture, Pain, Paracetamol, Emergency Department