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

October 8, 2021 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with femur fracture admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paracetamol IV
Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV).
Drug: Paracetamol
Paracetamol given orally or intravenously
Other Names:
  • Acetaminophen
  • N-acetyl-para-aminophenol
Paracetamol OR
Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR).
Drug: Paracetamol
Paracetamol given orally or intravenously
Other Names:
  • Acetaminophen
  • N-acetyl-para-aminophenol

What is the study measuring?

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).
Time Frame: 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)
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)
Time Frame: Baseline and 4 hours
identifies pain from 0 to 10 (with 0 = no pain and 10 = maximum pain intensity)
Baseline and 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Study Director: Francesco Franceschi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot. 36041/19 ID: 2727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results of the publication

IPD Sharing Time Frame

The data will be available immediately and ending 3 years after the publication of the study.

IPD Sharing Access Criteria

Proposals should be directed to francesco.franceschi@policlinicogemelli.it. To gain access, requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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