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

Phase 4

Completed

• Conditions: analgesia; moderate pain; comparative analgesic effectiveness; emergency medicine; Injuries and Accidents - Other injuries and accidents; Anaesthesiology - Pain management

• Registration Number: ACTRN12610000588099
• Lead Sponsor: Southern Health Emergency Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minimum fall in pain score of at least 20 mm on 100 mm visual analog scale from baseline pain score taken at triage.[Change in pain score from baseline compared to pain scores at 15, 30, 45 and 60 minutes post analgesia adminstration]

Secondary Outcome Measures

Name	Time	Method
se of rescue analgesia as assessed by lack of fall in pain score on visual analog scale administered by study researcher[60 minutes post-analgesia administration];Patient satisfaction with analgesia regimen assessed at end of study period by study researcher asking subject the degree of satisfaction on a three point satisfaction scale: 1) satisfied 2) not satisfied 3) unsure[60 minutes post-analgesia administration];Patient ability to indentify drug regimen prescribed to them. Subjects will be asked by a study investigator whether they think they received:<br>1) Paracetamol Ibuprofen and Thiamine<br>2) Paracetamol Ibuprofen and Oxycodone<br>3) Paracetamol Ibuprofen and Codeine[60 minutes post-analgesia administration]