Efficacy and safety of oxycodone hydrochloride injection for postoperative analgesia in patients undergoing operation under general anesthesia: a prospective, randomized, blind, multicenter, positive-controlled,clinical trial

Abstract

Objective To evaluate the efficacy and safety of oxycodone hydrochloride injection for postoperative analgesia in patients undergoing the operation under general anesthesia in a prospective,randomized,blind,multicenter,positive-controlled,clinical trial.Methods Two hundred and forty ASA Ⅰ or Ⅱ patients of both sexes,aged 18-64 yr,weighing 40-95 kg,scheduled for elective abdominal operation or orthopedic surgeries under general anesthesia,were randomly divided into 2 groups (n =120 each):morphine sulfate injection group (group M) and oxycodone hydrochloride injection group (group O).Morphine or oxycodone 1 mg was injected intravenously when the patients complained of pain after tracheal extubation or removal of the laryngeal mask,and administration was repeated if necessary until VAS≤40 mm.Then patient-controlled intravenous analgesia (PCIA) (100 ml,0.5 mg/ml) with morphine or oxycodone was used for postoperative analgesia (lasting for 48 h).The PCIA pump was set up with a 1 ml bolus dose,a 5 min lockout interval and background infusion at a rate of 0.5 mg/h.Pain at rest and during movement was assessed using VAS score at 3,24 and 48 h after administration,and non-inferiority test was performed.Total morphine or oxycodone consumption,requirement for rescue analgesic,the number of unsuccessfully delivered dose,the number of attempts,and the level of patient' s satisfaction were recorded within 48 h after operation.The adverse events were recorded and laboratory examinations (blood and urine routine test,blood biochemical examination) were performed within 72 h after administration.Results There was no significant difference in the VAS scores at rest and during movement at different time points,requirement for rescue analgesic,the number of unsuccessfully delivered doses and attempts,level of patient' s satisfaction,total morphine or oxycodone consumption,and adverse events between the two groups (P ＞ 0.05).No serious adverse event occurred in the two groups.The most common adverse event was nausea,followed by vomiting.There was no significant difference in the incidences and degree of nausea and vomiting between the two groups (P ＞ 0.05).The incidences of nausea and vomiting in patients underwent orthopedic surgeries were significantly lower in group O than in group M (P ＜ 0.05).The other adverse events were fewer and abnormal laboratory examinations were rare in the two groups.95％ confidence interval of the difference between the mean VAS scores at rest and during movement at each time point was within 15 mm (boundary values of non-inferiority testing) in the two groups.Conclusion PCIA with oxycodone hydrochloride injection is safe and effective in reducing pain after moderate or major operation,and the analgesic efficacy is similar to that of morphine sulfate injection,however,the development of nausea and vomiting is reduced when PCIA with oxycodone hydrochloride injection is used for orthopedic surgeries as compared with that when morphine sulfate injection is used and the ratio between the analgesic efficacy of the two drugs is close to 1∶1. Key words: Oxycodone ; Analgesia, patient-controlled ; Pain, postoperative