Comparison of tramadol-celecoxib co-crystal with tramadol or placebo for managing acute moderate-to-severe pain following oral surgery

According to a recent study, the co-crystal of tramadol-celecoxib (CTC) showed superior pain relief when compared to tramadol or placebo and also displayed an improved benefit/risk profile in comparison to tramadol. The findings were published in the journal Advances in Therapy.

A total of 726 adults were randomly assigned to five groups (2:2:2:2:1). Different treatment groups were assigned varying doses of medication, such as twice daily 100mg CTC (n = 164), 150 mg CTC (n = 160), or 200 mg CTC (n = 160), four times a day 100mg tramadol (n = 159), or  four times a day placebo (n = 83). Twice daily placebo was also given to individuals in the CTC groups. Total of pain intensity differences measured from 0 to 4 hours (SPID_0–4; visual analog scale) was the primary endpoint. The key secondary endpoints of the study assessed rescue medication use and 4-hour 50% responder rates. Safety endpoints included laboratory measures, adverse events, and the Opioid-Related Symptom Distress Scale (OR-SDS) score.

All CTC doses were more effective than placebo (P value < 0.001) for primary and key secondary endpoints. Additionally, they exhibited superiority over tramadol for SPID_0-4  (Analysis of covariance least squares mean differences [95% CI]: - 37.1 [- 56.5, - 17.6], - 40.2 [- 59.7, - 20.6], and - 41.7 [- 61.2, - 22.2] for 100 mg , 150 mg , and 200 mg CTC, respectively; P value < 0.001) and 4-hour 50% responder rate. The 4-hour 50% responder rates were 32.9% for CTC 100 mg, 33.8%  for CTC 150 mg, 40.6% for CTC 200 mg, 20.1% for tramadol, and 7.2% for placebo groups, respectively. Rescue medication consumption was less in the 100-mg (P value = 0.013) and 200-mg (P value = 0.003) CTC groups in comparison to the tramadol group. Tramadol by itself exhibited the highest occurrence of adverse events and OR-SDS scores.

Thus, it can be concluded that CTC provided superior pain relief compared to tramadol or placebo and also showed an improved benefit/risk profile in comparison to tramadol.