A randomised controlled trial of paracetamol and ibuprofen with or without codeine or oxycodone as initial analgesia for adults with moderate pain from limb injury.
OBJECTIVE
Compare pain relief from non-opioid, codeine and oxycodone analgesic regimens in adults with moderate pain from limb injury.


METHODS
Double-blind, randomised, controlled, non-inferiority trial. Three regimens of six tablets, each included 2 × 500 mg paracetamol and 2 × 200 mg ibuprofen with 2 × 100 mg thiamine (non-opioid), 2 × 30 mg codeine (codeine) or 2 × 5 mg oxycodone tablets (oxycodone).


METHODS
difference in mean visual analogue scale (VAS) change between groups at 30 min, with a limit of inferiority of 13. Secondary outcomes included mean change in VAS rating from baseline to 30 min for each group, patient satisfaction, need for additional analgesia and adverse events. Pain ratings taken at 60 and 90 min for patients still in ED are described.


RESULTS
Of 182 patients randomised, non-opioid, codeine and oxycodone numbers were 61, 62 and 59. Differences (95% CI) between groups at 30 min were as follows: non-opioid versus codeine -2.6 (-8.8 to 3.6); non-opioid versus oxycodone -2.7 (-9.3 to 3.9); codeine versus oxycodone 0.1 (-6.6 to 6.4). Mean VAS reductions for non-opioid, codeine and oxycodone were -13.5, -16.1 and -16.2 mm, respectively. Satisfaction with analgesia was reported by 77.6% (64.7-87.5), 81.0% (67.2-89.0) and 73.6% (59.7-84.7) and adverse events by 3.3% (0.4-11.3), 1.6% (0.4-8.7) and 16.9% (8.4-29.0), respectively. Mean VAS reductions at 60 and 90 min were as follows: -23.2 and -18.7 mm for non-opioid; -30.7 and -33.3 mm for codeine; and -26.1 and -31.7 mm for oxycodone.


CONCLUSIONS
At 30 min, analgesic effects of non-opioid, codeine and oxycodone groups were non-inferior.
Monash Health Emergency Medicine Research Unit, Dandenong Hospital, Melbourne, Victoria, Australia.|Monash Emergency, Dandenong Hospital, Melbourne, Victoria, Australia.|School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
Andis
http://orcid.org/0000-0002-0310-3983
A
Graudins
Monash Emergency, Dandenong Hospital, Melbourne, Victoria, Australia.|School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
Robert
R
Meek
Pharmacy Department, Monash Medical Center, Melbourne, Victoria, Australia.|School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
Jacqueline
J
Parkinson
Monash Emergency, Monash Medical Center, Melbourne, Victoria, Australia.|School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
Diana
D
Egerton-Warburton
Monash Emergency, Casey Hospital, Melbourne, Victoria, Australia.|School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
Alastair
A
Meyer
D000082:Acetaminophen / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000698:Analgesia / Q000379:methods*; D000700:Analgesics / Q000627:therapeutic use*; D003061:Codeine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009140:Musculoskeletal Diseases / Q000188:drug therapy*; D010098:Oxycodone / Q000627:therapeutic use*; D059408:Pain Management / Q000379:methods; D017060:Patient Satisfaction; D014947:Wounds and Injuries / Q000188:drug therapy; D055815:Young Adult
D000700:Analgesics; D000082:Acetaminophen; D010098:Oxycodone; D003061:Codeine; D007052:Ibuprofen
analgesia; emergency department; ibuprofen; opioid; paracetamol; randomised controlled trial