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

NCT ID: NCT05025228

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-06-30

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.

Conditions

Femur Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Paracetamol IV

Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV).

Paracetamol

Intervention Type: DRUG

Paracetamol given orally or intravenously

Paracetamol OR

Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR).

Paracetamol

Intervention Type: DRUG

Paracetamol given orally or intravenously

Interventions

Paracetamol

Paracetamol given orally or intravenously

Intervention Type: DRUG

Other Intervention Names

Acetaminophen; N-acetyl-para-aminophenol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Franceschi

Role: STUDY_DIRECTOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, , Italy

Countries

Italy

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Other Identifiers

Prot. 36041/19 ID: 2727

Identifier Type: -

Identifier Source: org_study_id