Comparative Effects of Premedication With Acetaminophen Versus Ketorolac on Postoperative Pain in 4–7-Year-Old Children Undergoing Dental Treatment Under General Anesthesia: A Parallel Triple-Blind Randomized Clinical Trial

Background: Pain is the most common complication of dental procedures under general anesthesia in children. Premedication with analgesics can decrease the need for intraoperative and postoperative analgesic administration. This study compared the effects of premedication with acetaminophen versus ketorolac on postoperative pain in 4–7-year-old children undergoing dental treatment under general anesthesia. Methods: This parallel triple-blind randomized clinical trial was conducted on 100 children requiring dental procedures under general anesthesia. The children were randomly allocated to two groups (n=50) by block randomization with size 4 blocks for premedication with either 10–12 mg/kg acetaminophen or 0.5 mg/kg ketorolac immediately after the onset of general anesthesia and before the onset of the dental procedure. The two groups were standardized regarding type of dental procedure, duration of anesthesia, age, and gender. The heart rate (HR), systolic blood pressure (SBP), and peripheral capillary oxygen saturation (SPO2) were recorded before and after the treatment. The pain intensity of patients was quantified at recovery time and 2 hours later using the Wong-Baker FACES Pain Rating Scale. The data were analyzed by the chi-square test, t-test, marginal modeling, and generalized estimating equations. Results: No significant difference existed in the mean pain score between the two groups during the recovery time (P=0.494), but the pain score was significantly lower in the ketorolac group after 2 hours (P=0.009). The mean reduction in the pain score within 2 hours was only significant in the ketorolac group (P=0.002). Conclusion: Acetaminophen and ketorolac were both effective for the reduction of postoperative pain in 4–7-year-old children undergoing dental treatment under general anesthesia, but ketorolac was significantly more effective after 2 hours.