Evaluation of oral ketorolac, oxycodone plus acetaminophen, and placebo for pain relief after orthopedic surgery

Abstract

This multicenter, randomized, controlled study evaluated the analgesic effects and safety profile of a single oral dose of ketorolac 10 mg (KET), oxycodone 5 mg plus acetaminophen 325 mg (OXY), and placebo (PLA) in patients with at least moderate pain after orthopedic surgery. Two hundred forty-two patients were enrolled. The three groups were demographically similar; mean age was 41.7 years. Pain intensity difference scores were greater in the OXY group at hour 2 postdose ( P=0.52) but were greater in the KET group at hours 5 and 6 ( P≤0.032). Summed pain intensity difference (SPID) scores were similar for both OXY and KET and significantly better than PLA at hours 3 and 6 ( P<0.001). Total pain relief scores at hours 3 and 6 were similar in the two active treatment groups and significantly better than in the PLA group ( P<0.0016). Minor side effects occurred in 42% of patients and were comparable in the two active treatment groups. Oral ketorolac is an effective postoperative oral analgesic medication that may be used as an alternative to oral opioids after orthopedic surgery.