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

NCT05025228 | Completed

• 1 other identifier: Prot. 36041/19 ID: 2727
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Femur Fracture

Keywords

Femur Fracture; Pain; Paracetamol; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain change of at least 2 points on the VAS scale at the 4 th hour (T4)

  Baseline and 4 hours

Study Arms (2)

Paracetamol IV

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

Drug: Paracetamol

Paracetamol OR

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

Drug: Paracetamol

Interventions

Paracetamol DRUG

Paracetamol given orally or intravenously

Also known as: Acetaminophen, N-acetyl-para-aminophenol

Paracetamol IV; Paracetamol OR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Allergy to paracetamol
• Unable to take analgesic therapy both orally (OR) and intravenously (IV)
• Unable to define pain by VAS

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, 00168, Italy

Location

Related Publications (31)

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  PMID: 30377550 RESULT

MeSH Terms

Conditions

Femoral Fractures; Pain; Emergencies

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Francesco Franceschi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 27, 2021
• Study Start: June 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 11, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available immediately and ending 3 years after the publication of the study.
• Access Criteria: Proposals should be directed to francesco.franceschi@policlinicogemelli.it. To gain access, requestors will need to sign a data access agreement.

Locations

IT (1)