Analgesia provided by intravenous paracetamol compared with intravenous morphine, for pain secondary to isolated limb trauma, in the emergency department: a pilot randomised trial
| ISRCTN | ISRCTN52451941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52451941 |
| Protocol serial number | 2188 |
| Sponsor | United Bristol Healthcare NHS Trust (UK) |
| Funder | College of Emergency Medicine (UK) |
- Submission date
- 16/06/2007
- Registration date
- 29/08/2007
- Last edited
- 29/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jonathan Benger
Scientific
Scientific
Emergency Department
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)1179 282713 |
|---|---|
| jonathan.benger@ubht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Anaglesia provided by paracetamol is equivalent to that provided by morphine. Added as of 31/12/2008: This trial has completed recruitment, data analysis ongoing. |
| Ethics approval(s) | North Somerset and South Bristol Research Ethics Committee, approved on 09/08/2007 (ref: 07/H0106/118) |
| Health condition(s) or problem(s) studied | Isolated limb trauma |
| Intervention | Intravenous paracetamol (1 g) or intravenous morphine (10 mg). |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Paracetamol , morphine |
| Primary outcome measure(s) | Visual analogue pain score, measured at 0, 5, 15, 30 and 60 minutes (the drug infusion starts at time 0). |
| Key secondary outcome measure(s) | 1. Requirement for rescue morphine 2. Patient satisfaction of overall analgesia on five point likert scale at 60 minutes 3. Occurence of side effects |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Isolated limb trauma 2. Moderate to severe pain, with initial verbal pain score of 7 or more 3. Age >15 and <65 years 4. Weight >50 kg |
| Key exclusion criteria | 1. Chest pain 2. Glasgow Coma Scale (GCS) <15 3. Allergy to morphine or paracetamol 4. Known liver disease, or patient clinically jaundiced 5. Major Trauma 6. Known pregnancy 7. Breast feeding 8. Patients requiring an immediate limb-saving procedure 9. Age <16 or >65 years 10. Patients in extreme distress who are unable to consent 11. Communication difficulties (foreign language, prior confusion) preventing informed consent or co-operation with pain scoring |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Emergency Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
