Contact information
Type
Scientific
Primary contact
Dr Jonathan Benger
ORCID ID
Contact details
Emergency Department
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
+44 (0)1179 282713
jonathan.benger@ubht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2188
Study information
Scientific title
Acronym
Study hypothesis
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
North Somerset and South Bristol Research Ethics Committee, approved on 09/08/2007 (ref: 07/H0106/118)
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Isolated limb trauma
Intervention
Intravenous paracetamol (1 g) or intravenous morphine (10 mg).
Intervention type
Drug
Phase
Phase IV
Drug names
Paracetamol , morphine
Primary outcome measure
Visual analogue pain score, measured at 0, 5, 15, 30 and 60 minutes (the drug infusion starts at time 0).
Secondary outcome measures
1. Requirement for rescue morphine
2. Patient satisfaction of overall analgesia on five point likert scale at 60 minutes
3. Occurence of side effects
Overall trial start date
01/09/2007
Overall trial end date
01/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/09/2007
Recruitment end date
01/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Emergency Department
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
United Bristol Healthcare NHS Trust (UK)
Sponsor details
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117928 3473
maria.palmer@ubht.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
University/education
Funder name
College of Emergency Medicine (UK)
Alternative name(s)
CEM
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21362724
Publication citations
-
Results
Craig M, Jeavons R, Probert J, Benger J, Randomised comparison of intravenous paracetamol and intravenous morphine for acute traumatic limb pain in the emergency department., Emerg Med J, 2012, 29, 1, 37-39, doi: 10.1136/emj.2010.104687.