Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial

Abstract

BackgroundSoft tissue injuries commonly present to the emergency department (ED), often with acute pain. They cause significant suffering and morbidity if not adequately treated. Paracetamol and ibuprofen are commonly used analgesics, but it remains unknown if either one or the combination of both is superior for pain control.ObjectivesTo investigate the analgesic effect of paracetamol, ibuprofen and the combination of both in the treatment of soft tissue injury in an ED, and the side effect profile of these drugs.MethodsDouble-blind, double dummy, placebo-controlled randomised controlled trial. 782 adult patients presenting with soft tissue injury without obvious fractures attending the ED of a university hospital in the New Territories of Hong Kong were recruited. Patients were randomised using a random number table into three parallel arms of paracetamol only, ibuprofen only and a combination of paracetamol and ibuprofen in a 1:1:1 ratio. The primary outcome measure was pain score at rest and on activity in the first 2 hours and first 3 days. Data was analysed on an intention to treat basis.ResultsThere was no statistically significant difference in pain score in the initial two hours between the three groups, and no clinically significant difference in pain score in the first three days.ConclusionThere was no difference in analgesic effects or side effects observed using oral paracetamol, ibuprofen or a combination of both in patients with mild to moderate pain after soft tissue injuries attending the ED.Trial registrationThe study is registered with ClinicalTrials.gov (no. NCT00528658).

Paracetamol: A Review of Guideline Recommendations

“…Clinical guidelines are updated periodically to keep up with new scientific discoveries, new treatments, and emerging pharmacoepidemiological data. The efficacy of paracetamol has been determined in RCTs as well as real-life studies to show its superiority versus placebo or other pain drugs [ 33 , 34 , 35 , 36 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 ]. However, recently, paracetamol failed to show superiority over placebo, and questions have been raised about its safety [ 70 ].…”

“…The pain intensity on the 0–100 mm VAS pain scale declined by 12, 12, and 13 mm, respectively, in the paracetamol, ibuprofen, and in the combined paracetamol and ibuprofen groups. The authors concluded that the treatments were clinically effective without significant differences between groups [ 60 ].…”

Acetaminophen, Nonsteroidal Anti‐inflammatory Drugs, or Combination of Both Analgesics in Acute Posttrauma Pain: A Randomized Controlled Trial

“…The second was conducted in 780 patients and compared three groups: paracetamol group, ibuprofen group, and a combination group. No difference was observed concerning the analgesic effects as well as the adverse effects 25 . The question then arises: why are the results of the available studies different?…”

Efficacy of acetaminophen versus ibuprofen for the management of rotator cuff-related shoulder pain: Randomized open-label study

“…We focused on the relatively long-term effects of treatment with ibuprofen and acetaminophen. Two relevant studies comparing these two drugs in patients with soft-tissue injuries [Dalton and Schweinle, 2006, Hung et al, 2018] were restricted to 2 and 4 days of follow-up, and did not find a difference in their analgesic effects. Thus, the disparate impact of ibuprofen and acetaminophen may become apparent after treatment for an extended period of time, a protocol which would be necessary for alleviating RC-related pain.…”