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
Secondary identifying numbers	2188

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jonathan Benger
Scientific

Emergency Department
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)1179 282713
Email	jonathan.benger@ubht.nhs.uk

Study design	Double-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	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 study start date	01/09/2007
Completion date	01/09/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Emergency Department

Bristol
BS2 8HW
United Kingdom

United Bristol Healthcare NHS Trust (UK)
Hospital/treatment centre

Marlborough Street
Bristol
BS2 8HW
England
United Kingdom

University/education

College of Emergency Medicine (UK)
Private sector organisation / Universities (academic only)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No