None listed
Conditions
Brief summary
The aim of our study is to compare the efficacy of a single dose paracetamol to a combination of pain relief with paracetamol, ibuprofen and codeine. Our hypothesis is that the combination will be significantly better than the single agent. This will then provide better guidance to clinicians on the use of pain relief in acute minor injuries that are presented to the Emergency Department, and to avoid over-prescribing of opioids. There are very good data internationally to show that the beginning of opioid addiction starts in the acute setting (Barnett 2017). We also know from many other studies that the combination of anti-inflammatories and paracetamol do not provide significantly more benefit compared to paracetamol alone (Man 2004, Woo 2005, Bondarsky 2013, Ridderikhof 2017). Other studies have also demonstrated that the combination of paracetamol and opioids to paracetamol and anti-inflammatories does not provide significant benefit (Graudins 2016, Chang 2017). There have also been a meta-analysis performed to compare anti-inflammatory only to a combination of pain relief which also showed similar efficacy (Jones 2015). Thus we will attempt to address the gap in our current literature of pain management by comparing paracetamol alone to a combination of all three agents.
Interventions
Study arm:
Paracetamol 500mgx2 oral tablets once
Ibuprofen 200mgx2 oral tablets once
codeine 60mgx1 oral capsule once
All are administered at the same time and only once.
Sponsors
Associate Professor Peter Jones
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed