Comparison of the analgesic efficacy of ketobemidone and morphine for management of postoperative pain in children:: a randomized, controlled study

Background: Ketobemidone has been used as an analgesic for postoperative pain in children, but to our knowledge the effect and occurrence of adverse effects of ketobemidone compared to morphine is not known. The aim was to determine if the analgesic potency and the occurrence of adverse effects of ketobemidone differ from morphine when administered to children, as measured by patient-controlled analgesia consumption (PCA) for postoperative pain. Methods: Sixty healthy children, aged 6 to 16 years, scheduled for elective surgery were randomized to receive either ketobemidone (Ke) 1 mg ml(-1) or morphine (Mo) 1 mg ml(-1) for postoperative pain through PCA. Drug consumption (mug kg(-1) h(-1)), the number of PCA doses, pain intensity, and adverse effects were recorded at regular intervals. Results: Data on total drug consumption were based on 26 children in the Ke group and 28 in the Mo group. A non-statistically significant difference for total mean consumption of ketobemidone (18.6 mug kg(-1) h(-1)) and morphine (23.2 mug kg(-1)h(-1)) was obtained. The mean dose ratio (Mo/Ke) was 0.80 and the median was 0.94. Children's characteristics, loading dose, PCA doses, VAS scores, and adverse effects showed no significant differences between the groups. Conclusion: The analgesic potency and adverse effects of ketobemidone are similar to morphine when used for postoperative pain management in children.