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

Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025228
• Other study ID #: Prot. 36041/19 ID: 2727
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Drug:
• Paracetamol
Paracetamol given orally or intravenously

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli, IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (31)

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Rowlands M, Walt GV, Bradley J, Mannings A, Armstrong S, Bedforth N, Moppett IK, Sahota O. Femoral Nerve Block Intervention in Neck of Femur Fracture (FINOF): a randomised controlled trial. BMJ Open. 2018 Apr 10;8(4):e019650. doi: 10.1136/bmjopen-2017-019650. — View Citation

Soffin EM, Gibbons MM, Wick EC, Kates SL, Cannesson M, Scott MJ, Grant MC, Ko SS, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Hip Fracture Surgery. Anesth Analg. 2019 Jun;128(6):1107-1117. doi: 10.1213/ANE.0000000000003925. Review. — View Citation

Uysal AI, Altiparmak B, Yasar E, Turan M, Canbek U, Yilmaz N, Gümüs Demirbilek S. The effects of early femoral nerve block intervention on preoperative pain management and incidence of postoperative delirium geriatric patients undergoing trochanteric femur fracture surgery: A randomized controlled trial. Ulus Travma Acil Cerrahi Derg. 2020 Jan;26(1):109-114. doi: 10.14744/tjtes.2019.78002. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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