None listed
Conditions
Brief summary
This study aims to find out whether adding an opioid painkiller (tapentadol) to standard pain relief (paracetamol and ibuprofen) provides better pain control than using standard pain relief alone after surgery for broken bones. Adults who have had surgery for a fracture will be randomly assigned to receive either tapentadol or a placebo for breakthrough pain during the first week after leaving hospital. The study will measure pain levels, recovery, and any side effects to help determine the safest and most effective way to manage pain after surgery following hospital discharge.
Interventions
Oral paracetamol sustained release (SR; 1330mg three times per day), oral nonsteroidal anti-inflammatory medication, ibuprofen (400mg three times per day) and oral tapentadol IR 50mg (every four hours, for breakthrough pain if needed) for a maximum of 1-week post-discharge.
Adherence to study medication (paracetamol and ibuprofen) will be measured by participants’ self-report of daily medication intake, recorded in a diary or online, and by counting the returned medications (tapentadol),
Sponsors
UNSW
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
Participants will be patients admitted to four trauma hospitals, with at least one acute fracture requiring surgical treatment. Eligible participants are required to have sustained an ‘orthopaedic fracture’ defined as a fracture of a long bone (i.e., humerus, radius, ulna, femur, tibia, or fibula) or the patella, calcaneus, or talus treated with surgical fixation; be age 18 years or older; and be able to comprehend the study protocol, written in English.
Exclusion criteria
Patients will be excluded if they are not being discharged directly home from hospital (for example, they are discharged to inpatient rehabilitation, nursing home or other institution), they have known or suspected multisystem trauma injuries (e.g., major head, chest, or abdominal injury); known or suspected major infection after surgical treatment; known or suspected opioid dependency; or contraindications to study treatment (such as, preexisting major gastrointestinal, cardiovascular or renal comorbidities), or are pregnant or breastfeeding.
Outcome results
None listed