CompletedPhase 4ACTRN12610000588099

Comparison of the effectiveness of three oral analgesic combinations in adults presenting to the Emergency Department with moderate pain from acute limb injury.

A double blind randomised controlled trial assessing the analgesic equivalency of oxycodone, paracetamol and ibuprofen with codeine, paracetamol and ibuprofen or paracetamol and ibuprofen alone in moderate pain from musculoskeletal limb injuries presenting to the emergency department.


Sponsor

Southern Health Emergency Research Group

Enrollment

216 participants

Start Date

Oct 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares three different combinations of common pain medications for adults aged 18 to 75 who come to the emergency department with moderate pain from a limb injury within the past 48 hours. It aims to find which combination works best for pain relief.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 paracetamo

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


Locations(1)

Australia

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ACTRN12610000588099