Morphine or Intravenous Paracetamol in Acutely Injured Neck of Femur Fractures

Phase 1

• Conditions: Fractured Neck of Femur; MedDRA version: 20.0Level: PTClassification code 10020100Term: Hip fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2017-003875-77-GB
• Lead Sponsor: niversity Hospitals of North Midlands NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-21
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

•18 years of age and above.
•Clinical suspicion of a fractured neck of femur.
•The patient has given informed consent or this has been gained from either the Personal or Professional Legal Representative.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

•There is clinical suspicion that the patient has other fractured bones.
•The patient has had any form of hip replacement on the affected side.
•Glasgow Coma Scale less than 14.
•Paracetamol or morphine has been received in the last 4 hours.
•Known allergy to morphine or paracetamol.
•Contraindications for IV morphine or paracetamol (as detailed in the product SmPC).
•Pre-diagnosed liver disease.
•Known pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study aims to address the question: Does Intravenous Paracetamol provide any less pain relief than intravenous Morphine in controlling severe pain for acute neck of femur fractures with less side effects?;Primary end point(s): The primary outcome will be the patient’s pain levels which will be assessed using an anchored 100mm VAS at 0, 15, 30, 60 and 120 minutes after administering pain relief. <br><br>;Secondary Objective: The study also aims to find out the number, type and severity of side effects, to assess if intravenous paracetamol is safer to use than intravenous morphine at the current recommended dosages used for both drugs. The requirement for any additional pain relief will be assessed, and the costs of drug administration, consumables and staff costs.;Timepoint(s) of evaluation of this end point: The time points are 0,15,30,60 and 120 minutes

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •The number of adverse events that are identified within the 120 minutes. <br>•The type and severity of adverse events and SAEs.<br>•The requirement for and amount of rescue analgesia required.<br>•Generic health status measured by completion of EQ-5D5L at baseline and 120 minutes<br>•The cost of IV paracetamol and IV morphine in fractured NOF patients in terms of pain relief and adverse events, including the cost of the drugs and their administration, and requirement for additional drugs and resources in management of side effects.<br>;Timepoint(s) of evaluation of this end point: Within 120 minutes and length of hospital stay at 7 days