DOI: https://dx.doi.org/10.18203/2320-1770.ijrcog20222631
Published: 2022-10-28

Assessing the impact of a fixed dose combination of camylofin and mefenamic acid on the onset of pain relief in patients with moderate to severe dysmenorrhea

Pragya Pandey

Abstract


Background: A fixed-dose combination (FDC) of camylofin 50 mg and mefenamic acid 250 mg was found to be effective and safe following 5 days of treatment in women with primary dysmenorrhea. Here, we assess the onset of analgesia FDC within 24 hours of administration of the FDC using two independent patient-reported outcome tools.

Method: In this prospective, single-center study, 140 women with moderate-to-severe primary dysmenorrhea received 3 tablets of the FDC over 24 hours. Primary endpoints were time to pain relief using the 11-point numerical rating scale (NRS-11) and the 100-mm visual analog scale (VAS) and proportion of patients with pain relief in the first 2 hours post-1st dose administration. Pain relief was defined as ≥1-point reduction in pain score on both scales. Secondary endpoints were change in pain intensity scores from baseline to 24 hours post-1st dose using both scales and incidence of adverse events (AEs).

Results: Median duration of onset of pain relief using NRS-11 and VAS was 50-and 20-minutes post-1st dose, respectively. Statistically significant reductions (p˂0.0001) post 1st dose was observed from 40 minutes on the NRS-11 and at all post-baseline timepoints on the VAS. Only 3 patients (2.1%) reported treatment emergent AEs, all of which were related to the study drug, ‘mild’ in intensity, and resolved without sequalae.

Conclusions: The FDC of camylofin and mefenamic acid provided analgesia onset within 20 min on VAS and 50 min on NRS after administration of first dose and a good safety profile in women with primary dysmenorrhea.

 


Keywords


Camylofin, Mefenamic acid, Primary dysmenorrhea, 11-point numerical rating scale, Visual analog scale

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References


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