Condition category
Signs and Symptoms
Date applied
16/06/2007
Date assigned
29/08/2007
Last edited
29/03/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ubht.nhs.uk/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21362724

Publication citations

  1. 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.

Additional files

Editorial Notes