A Randomized Trial Evaluating the Synergistic Effect of Parenteral Diclofenac and Paracetamol for Pain Management in Adult Males With Acute Limb Injury
Abstract
Introduction: In the emergency department (ED), commonly used analgesics for pain management are nonsteroidal anti-inflammatory drugs (NSAIDs), paracetamol, and opioids. The aim of this clinical trial was to evaluate the effectiveness of intravenous (IV) or oral (PO) paracetamol, combined with intramuscular (IM) diclofenac, in patients with acute limb injuries.
Methods: This study utilized a double-blind, randomized controlled design to evaluate three different treatment groups. The trial included healthy adult males aged 18-65 years, who arrived at the ED with acute limb injuries, and an initial pain score of at least 5 on the Numerical Rating Scale (NRS). Participants were randomly assigned in equal numbers to one of three groups: one group received IM diclofenac (75 mg/3 mL), along with oral paracetamol (1000 mg); the second group was given IM diclofenac plus IV paracetamol (1000 mg in 100 mL); and the third group received IM diclofenac (75 mg/3 mL), accompanied by a placebo. The main goal of the study was to compare the average pain reduction among the three groups at 30 min after treatment (t30).
Results: A total of 162 participants were recruited between October 2022 and February 2023. Pain levels were assessed at baseline (t0) and continued to be monitored up to 90 min after medication was administered (t90). The average reduction in pain scores for each group was as follows: diclofenac plus oral paracetamol resulted in a mean decrease of 2.5 ± 0.03, diclofenac plus…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 162 participants or records.
Read the paper
Related studies
- Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial
- Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial
- Comparison of the Post-Caesarean Analgesic Effect of Adding Dexmedetomidine to Paracetamol and Ketorolac: A Randomized Clinical Trial
- A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions
- An open label randomized clinical trial of Indomethacin for mild and moderate hospitalised Covid-19 patients
- Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.