Morphine or IV Paracetamol in Acutely Injured Neck of Femur Fractures
Research type
Research Study
Full title
A Randomised, Controlled Double Blinded Non-inferiority Trial of intravenous Morphine compared with intravenous Paracetamol for pain relief in patients presenting to the Emergency Department with Suspected Acute Fractured Neck of Femur.
IRAS ID
233701
Contact name
Mark Poulson
Contact email
Sponsor organisation
University Hospitals of North Midlands NHS Trust
Eudract number
2017-003875-77
Duration of Study in the UK
1 years, 6 months, 7 days
Research summary
Fractured neck of femur, also known as fractured hip, is an extremely painful condition requiring rapid pain relief. In the UK, 70,000 patients, predominantly elderly, are treated in hospital emergency departments annually for fractured hips, often following falls. Pain relief treatments for a fractured hip currently include morphine or paracetamol delivered into the bloodstream. Whilst morphine offers pain relief, it can cause side-effects including nausea, vomiting, breathing difficulties and low blood pressure. These side-effects are common among elderly patients. Morphine is also a controlled drug and may cost more to administer as it requires presence of 2 staff members when authorising its use. Furthermore, morphine may require additional costly resources and medications to manage its side-effects.
When paracetamol is delivered into the bloodstream it is thought to have similar pain relief and fewer side-effects than morphine in treatment for several conditions. Therefore, current guidelines instruct use of paracetamol delivered into the bloodstream for pain relief for patients with a fractured hip. However, most emergency departments use morphine because there is no high-quality evidence to support the guidelines.
We aim to provide this evidence by performing a trial to assess whether use of paracetamol is not inferior to morphine for pain relief and causes fewer side-effects in patients with a fractured hip. Patients will be given either paracetamol or morphine and within the 2 hours following treatment, the team will assess patient-reported pain relief, side-effects, requirement for additional pain relief, blood pressure pulse rate, respiratory rate and blood oxygen levels. The cost-effectiveness of each treatment will also be assessed by looking at costs of giving the drugs and resources and medications needed to manage the side-effects of each drug. This study will provide high-quality evidence to support the most effective management of pain for a fractured hip.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0404
Date of REC Opinion
24 Jan 2018
REC opinion
Further Information Favourable Opinion