A Comparative Analysis of the Efficacy and Safety of Nimesulide/Paracetamol Fixed-Dose Combination With Other NSAIDs in Acute Pain Management: A Randomized, Prospective, Multicenter, Active-Controlled Study (the SAFE-2 Study)

Objective In this study, we aimed to compare the efficacy and safety of the fixed-dose combination (FDC) of nimesulide (100 mg) + paracetamol (325 mg) [NP], ketorolac (10 mg) [Kt] alone, diclofenac (50 mg) + paracetamol (325 mg) [DP], and aceclofenac (100 mg) + paracetamol (325 mg) [AP] in patients...

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Published in:Curēus (Palo Alto, CA) CA), 2024-04, Vol.16 (4), p.e58859-e58859
Main Authors: Patil, Sandip, Nadaf, Naushad, Gupta, Sabyasachi, Barai, Pratik, Makhija, Swati, Lodha, Prateek, Patel, Chintan, Gondane, Ajitkumar A, Pawar, Dattatray, Sharma, Akhilesh
Format: Article
Language:English
Subjects:
Analgesics
Arthritis
Back pain
Biochemistry
Bursitis
Chronic pain
Clinical medicine
Creatinine
Drug dosages
Electrocardiography
Hematology
Liver
Migraine
Musculoskeletal diseases
Nonsteroidal anti-inflammatory drugs
Pain management
Surgeons
Tendinitis
Trauma
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Summary:Objective In this study, we aimed to compare the efficacy and safety of the fixed-dose combination (FDC) of nimesulide (100 mg) + paracetamol (325 mg) [NP], ketorolac (10 mg) [Kt] alone, diclofenac (50 mg) + paracetamol (325 mg) [DP], and aceclofenac (100 mg) + paracetamol (325 mg) [AP] in patients with acute painful conditions. Methods This was a randomized, prospective, open-label, multicentre, active-controlled study involving patients aged ≥18 years, with acute painful conditions like low back pain, acute musculoskeletal disorders, and trauma such as tendinitis, tenosynovitis, bursitis, sprains and strains, migraine, dental pain, painful dental procedures, and post-surgical pain. Reduction in pain intensity and liver, renal, gastrointestinal, and cardiovascular safety were assessed on days seven and 14. Results A total of 600 patients were randomized into NP, Kt, DP, and AP groups in a 1:1:1:1 ratio. NP, DP, and AP were administered twice a day while Kt was given three times a day. The reduction of pain as measured by the numerical rating scale (NRS) scores at the end of day seven was 3.75 ± 1.58 in the NP group, 2.96 ± 1.18 in the Kt group, 3.42 ± 1.42 in the DP group, and 3.47 ± 1.30 in the AP group. The pain reduction in the NP group was significantly greater (p
ISSN:2168-8184
2168-8184
DOI:10.7759/cureus.58859