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Completed

NCT Number: NCT05025228

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

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

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Key information

Conditions

Femur Fracture Disease Attributes Emergencies Femoral Fractures Fractures, Bone Leg Injuries Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

Paracetamol given orally or intravenously

Other names: Acetaminophen, N-acetyl-para-aminophenol

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2021
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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