Short-Term Efficacy and Safety of Sublingual Ketorolac–Tramadol (ketotram) Combination in Acute Exacerbations of Knee Osteoarthritis: A Prospective Case Series.

Abstract

Osteoarthritis of the knee is commonly associated with pain, stiffness, and functional limitation, with acute exacerbations requiring effective short-term analgesia. This prospective case series evaluated the short-term clinical response and tolerability of a sublingual ketorolac–tramadol combination in patients with acute exacerbations of symptomatic unilateral knee osteoarthritis. Fifteen patients with moderate symptomatic knee osteoarthritis received sublingual ketorolac 10 mg plus tramadol 25 mg twice daily for 5 consecutive days. Paracetamol 650 mg was used as rescue medication. Pain intensity and osteoarthritis-related functional status were assessed using the Numerical Rating Scale (NRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and Day 5. Patient-reported treatment response, rescue analgesic requirement, and adverse events were also recorded. The mean NRS score decreased from 6.67 ± 0.82 at baseline to 3.60 ± 1.40 on Day 5, representing a mean reduction of 3.07 points (paired t-test, t = 10.21, p < 0.001). Mean WOMAC score decreased from 59.80 ± 1.57 to 35.27 ± 3.81, with a mean reduction of 24.53 points (t = 22.87, p < 0.001). The mean Likert score for overall treatment response was 3.73 ± 0.59. Fourteen patients (93.3%) required no rescue analgesia, while one (6.7%) required paracetamol 650 mg. No adverse events were reported during the 5-day observation period. These preliminary findings suggest favourable short-term clinical response and tolerability; however, the small sample size, absence of a comparator, concomitant paracetamol use, and short follow-up limit causal interpretation. Larger controlled studies are warranted