Paracetamol versus combination analgesics for injury pai

Completed

• Conditions: Pain; Injuries and Accidents - Other injuries and accidents; Anaesthesiology - Pain management

• Registration Number: ACTRN12618000020280
• Lead Sponsor: Associate Professor Peter Jones

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-11
• Study Completion: 2018-11-25
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

•Age: 18-65
•Moderate to severe pain (3/10 or higher on a Verbal Rating Scale 0-10 on admission)
•Acute closed limb or trunk injury (previous 48 hour)
•Oral analgesia deemed suitable

Exclusion Criteria

•Need for time critical interventions (e.g. reduction of dislocations)
•Digital injuries (treated with nerve blocks)
•Pregnant or breastfeeding women
•NSAID sensitive asthma
•Active peptic ulcer disease
•Known renal function impairment
•Known liver function impairment
•Acute intoxication (any substance)
•Already received analgesia within four hours prior to admission
•Regular use of analgesic agents for chronic pain
•Allergies or prior adverse reaction to any of the study medications
•Inability to take oral medication
•Inability to understand the study explanation (any reason)
•Unwillingness to comply with recommendations to not drive, consume alcohol or operate machinery for at least 6 hours after being given the study medication
•Open injuries
•Patient with multi-trauma
•Patient with head injuries

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in mean pain score based on a standard 11 point verbal rating scale (VRS) between groups, The 11 point VRS is a standard tool to assess level of pain that is used in our Emergency Department.<br>A 1.3 difference been nominated as clinically detectable. <br>[60 minutes post randomisation]

Secondary Outcome Measures

Name	Time	Method
umber of patients required rescue analgesia via documentation in the study tool kit and standard national drug chart. [120 minutes post randomisation];Adverse effects will be limited to a questionnaire of yes/no, if patient does say 'yes' then the full details of the adverse reaction including:<br>* What Adverse effect was experienced<br>* Brief description of the adverse effect<br>* Severity <br>* Action taken[60 minutes and 120 minutes]