Morphine or iv paracetamol in acutely injured neck of femur fractures
| ISRCTN | ISRCTN17370874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17370874 |
| EudraCT/CTIS number | 2017-003875-77 |
| Secondary identifying numbers | 36716 |
- Submission date
- 04/12/2017
- Registration date
- 12/01/2018
- Last edited
- 11/04/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
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. The aim of this study is 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. This study will provide high-quality evidence to support the most effective management of pain for a fractured hip.
Who can participate?
Adults aged 18 and older who have a suspected fracture neck of the femur.
What does the study involve?
Participants are randomly allocated to receive either paracetamol or morphine and within the two hours following treatment, the team assesses 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.
What are the possible benefits and risks of participating?
There is not expected to be any direct benefits or risks for taking part in the study as both treatments are used in normal clinical care for pain relief in patients with fractured hips. However, it is hoped that this trial will be able to give further information about the best treatment to give to these patients.
Where is the study run from?
Royal Stoke University Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2017 to January 2020
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Liz Hartshorne (Scientific)
l.hartshorne@keele.ac.uk
Contact information
Scientific
Research & Development Department
Courtyard Annexe – C Block
Royal Stoke University Hospital
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
| Phone | +44 (0)1782 675383 |
|---|---|
| callam.weldon@uhnm.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Drug |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific 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 |
| Study hypothesis | The aim of this study is 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. |
| Ethics approval(s) | Yorkshire & The Humber – Leeds East Research Ethics Committee, 05/12/2017, ref: 17/YH/0404 |
| Condition | Fractured neck of femur, also known as fractured hip |
| Intervention | Patients are given either IV paracetamol or IV morphine and within the 2 hours following treatment. The team assesses patient-reported pain relief, side-effects, requirement for additional pain relief, blood pressure pulse rate, respiratory rate and blood oxygen levels. There are no further follow-up other than noting length of hospital stay. The cost-effectiveness of each treatment is also assessed by looking at costs of giving the drugs and resources and medications needed to manage the side-effects of each drug. |
| Intervention type | Other |
| Primary outcome measure | Pain is measured using a 100mm visual analogue scale (VAS) at 0, 15, 30, 60 and 120 minutes. |
| Secondary outcome measures | 1. The number of adverse events, type, severity and seriousness are measured by patient report or measurement of blood pressure, pulse rate, respiratory rate and blood oxygen levels within the 120 minutes 2. The requirement for and amount of rescue analgesia required within the 120 minutes are recorded on the patient notes and study case report form 3. Generic health status is measured by completion of EQ-5D at baseline and 120 minutes 4. The cost of IV paracetamol and IV morphine in fractured Neck Of Femur patients is measured in terms of pain relief and adverse events (measured as above), including the cost of the drugs and their administration, and requirement for additional drugs and resources in management of side effects |
| Overall study start date | 11/07/2017 |
| Overall study end date | 31/01/2020 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 338; UK Sample Size: 338 |
| Participant inclusion criteria | 1. 18 years of age and above 2. Clinical suspicion of a fractured neck of femur 3. The patient has given informed consent or this has been gained from either the Personal or Professional Legal Representative |
| Participant exclusion criteria | 1. There is clinical suspicion that the patient has other fractured bones 2. The patient has had any form of hip replacement on the affected side 3. Glasgow Coma Scale less than 14 4. Paracetamol or morphine has been received in the last 4 hours 5. Known allergy to morphine or paracetamol 6. Contraindications for IV morphine or paracetamol (as detailed in the product SmPC) 7. Pre-diagnosed liver disease 8. Known pregnancy |
| Recruitment start date | 01/04/2018 |
| Recruitment end date | 30/09/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Staffordshire
Stoke-on-Trent
ST4 6QG
United Kingdom
Sponsor information
Hospital/treatment centre
Newcastle Road
Stoke-On-Trent
ST4 6QG
England
United Kingdom
| Phone | +44 1782 675381 |
|---|---|
| research.governance@uhnm.nhs.uk | |
"ROR" |
https://ror.org/03g47g866 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from academic.research@uhnm.nhs.uk. Core data will be available immediately after main publication. A data request form is required to be completed and must outline the type of data to be obtained, the reason for obtaining this data (research question / objective), the timing for when the data is required to be available (start date/end date). Checks will be performed by the Quality Assurance Steering Group to ensure that the data set requested is appropriately suited to answer the research question/objective and that the request fits with the original ethical approval and participant consent and adheres to funder and legal restrictions. Only de-identified data are available for request in aggregated format or at the level of the individual participant. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/04/2019: The trial closed early on 26/03/2019 as it was not possible to continue with the planned methodology of the trial due to the legislative issue around the administering of IMP and placebo by the paramedics, this resulted in the trial IMP not being delivered as per the current protocol (i.e. as saline is a prescription medicine it can only be delivered in the same line as active drug under the written direction of a doctor for a named patient).
20/12/2018: A telephone number has been added for the scientific contact.
19/12/2018: The scientific contact has been changed from Liz Hartshorne to Callam Weldon.
