None listed
Conditions
Brief summary
Very little information exists on the effectiveness of oral pain-relieving medication administered acutely to adult patients presenting to the Emergency Department (ED) with moderate pain. As a result, the most effective combination of pain-relievers for acute pain is unknown. Studies in children in the emergency setting have suggested that a number of pain reliever combinations may be equally as effective for the treatment of moderate pain. Similar studies have not been replicated in adults. Southern Health (SH) Emergency Medicine has an established guideline for the management of patients presenting to the Emergency Department with pain. The triage Nurse may administer one of a number of combinations of pain relieving medications provided certain clinical requirements are met. However, the guideline for pain relief when a patient has moderate pain (pain score >3 and <8), is not clear, suggesting the administration of a number of pain relief alternatives. These include; paracetamol with oxycodone and Ibuprofen, or alternatively Panadeine Forte-Registered Trademark (R) (paracetamol & codeine phosphate) with or without ibuprofen. It is not clear from past research whether or not one combination is superior. Additionally, the ease of nursing accessibility varies with oxycodone and Panadeine Forte(R) due to the different drug schedule of each pain reliever. Oxycodone is an S8 drug, requiring a higher degree of security and accountability to dispense. This has implications for nursing time to retrieve and give the drug to patients. Anecdotally, there is a perception by some emergency nursing staff that it may be easier or quicker to administer Panadeine Forte(R) compared to oxycodone. Some studies done in other settings suggest that oxycodone with paracetamol may be a more effective pain reliever for acute pain than Panadeine Forte(R), but data is conflicting and despite numerous systematic reviews of both pain relievers the differences may be small in patients with moderate pain. In the initial management of moderate pain at triage, the small benefit oxycodone+paracetamol confers over Panadeine Forte (R) may be offset by the added time it takes to deliver the former agent to the patient and the subsequent time of onset of pain relief. Our study intends to compare three widely accepted combinations of analgesics for treatment of moderate pain in adults who present to the ED following acute limb injury. Firstly, paracetamol 1g with ibuprofen 400mg will be compared to 2) Codeine Phosphate 60 mg with paracetamol 1g and ibuprofen 400mg and, 3) Oxycodone (Endone (R)) 10 mg with paracetamol 1g and ibuprofen 400mg. All of these drugs are currently included in some combination in the current Southern Health Emergency Medicine nurse-initiated pain guideline for management of moderate pain. The study will be carried out in all three Southern Health EDs. Subjects will be given one of three randomly assigned and unknown combinations of the drugs. Their pain scores will be determined at regular intervals for 90 minutes. There will be regular monitoring for side effects and for the need for additional painkillers. We aim to recruit 216 subjects. Equal relief of pain with all the regimens may improve delivery of pain relief in the ED by reducing the need to access S8 medications in moderate pain, thus reducing time to delivery of effective analgesia. If the oxycodone arm is found to provide superior analgesia the current guideline could be amended to simplify the currently recommended treatment options. Alternatively if it is found the arm without opioid analgesia is equivalent the routine use of codeine and oxycodone for moderate pain will be reviewed.
Interventions
Arm 1) oxycodone 10 mg oral tablet with paracetamol 1000 mg oral tablet with ibuprofen 400 mg oral tablet administered simultaneously as a single dose
Arm 2) codeine 60 mg oral tablet with paracetamol 1000 mg oral tablet with ibuprofen 400 mg oral tablet administered simultaneously as a single dose
Sponsors
Southern Health Emergency Research Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) Adult patients greater than or equal to18 years old and less than or equal to 75 years old AND 2) Limb injury within the preceding 48 hours AND 3) Initial verbal pain score elicited by the Triage Nurse of greater than 3/10 to less than or equal to 7/10 (ie 4 to 7/10)
Exclusion criteria
Need for any time critical interventions (e.g. reduction of dislocations or compound fractures) . Digital injuries (pain from these should ideally be treated with digital block). Pregnant and breastfeeding women (paracetamol and codeine are Category A drugs but Ibuprofen and oxycodone are Category C; with regard to lactation, paracetamol and ibuprofen are considered safe, but codeine and oxycodone are not recommended). Asthma that may be Non-Steroidal Anti-inflammatory Drug (NSAID) sensitive. Active peptic ulcer disease. Known renal impairment. Ethanol or recreational drug abuse or acute intoxication. Use of any analgesic or sedating agent in the preceding 4 hours . Regular use of analgesic agents for chronic pain. Inability to take oral analgesics. Known allergy or intolerance to paracetamol, to any opiate, or to any NSAID including Aspirin. Patients not willing to comply with the recommendation not to drive, consume alcohol or operate machinery for at least 8 hours after being given the study drug combination. Patients unable to understand the study explanation or unwilling to participate for whatever reason.
Outcome results
None listed