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A randomised control trial of mild opioids versus strong opioids for post-discharge analgesia following orthopaedic fracture surgery

A randomised control trial of oxycodone hydrochloride versus paracetamol with codeine for post-discharge analgesia following orthopaedic fracture surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000941460
Enrollment
120
Registered
2016-07-15
Start date
2016-07-27
Completion date
2017-10-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Opioid analgesics (morphine-like pain killers) are the drug of choice for post-operative pain fracture management. Previous research has been found that most, if not all, surgically managed fracture patients are discharge home from hospital with strong opioids (largely Panadiene Forte, Endone and Oxycontin). Despite the overwhelming push for effective postoperative pain control, at present there is no clear consensus on which pain medication is best for pain management after discharge home from hospital following an orthopaedic fracture. We aim to determine whether over the counter paracetamol plus codeine provides adequate pain relief compared to stronger oxycodone based pain killers.

Interventions

Paracetamol 500mg and Codeine phosphate 8mg 1-2 oral tablets, 4 times per day for 2 weeks (Maximum allowed 8 tablets in 24hrs) followed by dose reduction to cessation during week 3. Total number of tablets taken (1 or 2) will be determined by patient during days 1 -14. Adherence will be monitored via patient self-report during trial period then tablet return on study completion.

Sponsors

Professor Ian Harris
Lead SponsorIndividual

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 No maximum
Healthy volunteers
No

Inclusion criteria

Orthopaedic fracture of a long bone (humerus, radius, ulna, femur, tibia or fibula) or the pelvis, patella, calcaneus or talus requiring surgical fixation.

Exclusion criteria

- Pathological fractures - Multi-system trauma injuries (major head, chest or abdominal injuries) - Major infection following surgery - Opioid dependency

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026