Original ResearchRandomized Double-Blind Trial Comparing Oral Paracetamol and Oral Nonsteroidal Antiinflammatory Drugs for Treating Pain After Musculoskeletal Injury
Introduction
Nonsteroidal antiinflammatory drugs are widely used. In the western world, it is estimated that almost 10% of the population have used a nonsteroidal antiinflammatory drug at some time and that an average of 11 to 36 people per 1,000 population consume a nonsteroidal antiinflammatory drug each day.1, 2 These drugs have antiinflammatory, analgesic, antipyretic, and antithrombotic effects3 yet have no known effect on disease processes itself. They are currently indicated for many acute and chronic musculoskeletal problems of mild to moderate pain intensity.
A recent Cochrane review of randomized clinical trials found little evidence of any difference in efficacy or dose effect between different nonsteroidal antiinflammatory drugs in the management of rheumatoid arthritis, osteoarthritis, or acute musculoskeletal syndrome.4 No large, double-blind, randomized, controlled trial with more than 100 participants has compared paracetamol with nonsteroidal antiinflammatory drugs in the treatment of pain in acute musculoskeletal syndromes.4 Our study aimed to recruit a sufficient number of subjects in order to demonstrate the efficacy of nonsteroidal antiinflammatory drugs versus paracetamol. Readers would then have a better guide in choosing analgesics in a more cost-effective manner.
The aim of this study is to compare the analgesic efficacy and safety of oral nonsteroidal antiinflammatory drugs with oral paracetamol or diclofenac-paracetamol combination therapy in the management of pain after acute musculoskeletal syndrome in an emergency department (ED) setting. We hypothesized that paracetamol would be as efficacious as nonsteroidal antiinflammatory drugs or combination therapy in the management of acute pain and would be associated with fewer adverse events. Participants were randomized into 4 groups, and each received combinations of analgesics or placebo. Pain scores were measured in 2 stages: acutely in the ED (stage 1) and for 3 consecutive days after discharge (stage 2). The occurrence and severity of adverse effect were also recorded at each stage.
Section snippets
Study Design
This was a randomized, double-blind, controlled trial comparing 3 drugs, namely, paracetamol, indomethacin, and diclofenac potassium. After checking that participants satisfied the predetermined inclusion and exclusion criteria, subjects were randomized into 4 groups. Each group received 2 study drugs (X and Y). Drug X could be either paracetamol or paracetamol-like placebo. Drug Y could be indomethacin, indomethacin-like placebo, or diclofenac potassium. Pain scores were recorded by a
Results
Between January 7, 2002, and June 24, 2003, 300 patients attended the ED between 9 am and 5 pm, Monday to Friday, with acute painful musculoskeletal injuries were allocated to receive blinded analgesia (Figure 1). Baseline characteristics of the participants in the 4 groups were similar (Table 1). Because of the triage and consenting processes involved in the study, 35 to 40 minutes passed between arrival at the department and initiation of analgesia. Initial mean pain scores at rest were mild
Limitations
The strengths of the study lie in its randomized, controlled design; its simple, practical, safe method of delivery of analgesia; and in its attempt to reflect the real world as far as reasonably possible. The doses of nonsteroidal antiinflammatory drugs used in this study reflected normal prescribing practice in our department. We have sought to reflect our real world, but these doses may be lower than those used in other health care settings. It is possible that higher doses produce a greater
Discussion
These results show that at the doses, frequencies, and routes of administration used in this study, oral paracetamol appears to be as effective as oral indomethacin, oral diclofenac, and oral diclofenac-paracetamol combination in the management of pain in musculoskeletal syndrome of minor to moderate severity. At the doses, frequencies, and durations used in the treatment of these participants, there were no severe adverse events and no significant differences in the proportion of patients with
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Comparison of intravenous ibuprofen and paracetamol efficiency in soft tissue injuries: A randomized, double-blind study
2020, American Journal of Emergency MedicineOral Paracetamol Versus Combination Oral Analgesics for Acute Musculoskeletal Injuries
2019, Annals of Emergency MedicineCitation Excerpt :At the standard doses studied, supplementing acetaminophen with ibuprofen and codeine does not enhance analgesia. Several studies compared paracetamol with a combination of paracetamol and nonsteroidal anti-inflammatory drugs, finding no clinically important differences in analgesic efficacy and adverse events.3-7 Another study compared the addition of opioids with paracetamol and nonsteroidal anti-inflammatory drugs in this setting, also finding no difference in analgesia.8
Intravenous paracetamol versus dexketoprofen in acute musculoskeletal trauma in the emergency department: A randomised clinical trial
2019, American Journal of Emergency MedicineCitation Excerpt :There was no statistically significant difference between the two drug groups [20]. Woo et al. compared the efficacy of oral paracetamol (1 g), diclofenac (25 mg) and indomethazine (25 mg) in patients presenting with musculoskeletal trauma, and the decrease in VAS in groups was found to be similar, underlining the fact that NSAIDs, paracetamol, paracetamol + diclofenac combination were equally safe in reducing musculoskeletal pain [21]. In a randomised, double-blind study by Akil et al., who considered the use of paracetamol and dexketoprofen administered intravenously for non-traumatic musculoskeletal pain, similar drug doses ― dexketoprofen 50 mg IV for the first group (n = 49), paracetamol 1 g IV for the other group (n = 46) ― were applied.
Supervising editor: Knox H. Todd, MD, MPH
Author contributions: TR had the idea for the study, obtained approval, and has overseen the entire planning, execution, analysis, and preparation of manuscript. He is guarantor of the work. WKW and SYM participated in the planning, execution, and analysis. PL and TR prepared the statistical analysis. TR wrote the first draft of the paper, and all authors have contributed to the final version. TR takes responsibility for the paper as a whole.
Funding and support: The authors report this study did not receive any outside funding or support.