The comparison of analgesic effects of intravenous and intranasal Ketorolac on patients undergoing mandibular fracture surgery-A Randomized clinical trial

Abstract

Introduction: internasal spary is a new form of Ketorolac which has been introduced in recent years. Its pharmacokinetics similarity to the intravenous form and other advantages has promoted its application. This study aimed to compare the analgesic effects of intravenous and intranasal Ketorolac on patients undergoing mandibular fracture surgery. Materials and Methods: In this clinical trial which was conducted from March to February 2018 in Imam Reza Hospital of Tabriz, 64 patients with unilateral mandibular fracture were divided randomly into two group. In the first group, 30mg of intravenous (IV) Ketorolac was injected every 8 hours and in the second group, intranasal Ketorolac spray (IN) was used as 100ul puff in each nostril (31.5mg) every 6 hours. After each patient regained complete consciousness, pain intensity based on Visual Analogue Scale was measured for 48 hours at hours 0, 2, 4, 6, 12, 24, 36 and 48. Finally, the total dose of the opioid analgesic agent (pethidine) and the time for the first request for an analgesic agent were recorded for each patient, and their means were compared in each group with suitable statistical tests. Results: In this study, 64 patients (48 men and 16 women) with mean age of 14.7±33.7 were evaluated. Mean pain intensity of patients at baseline was significantly higher than other times and then, it reduced significantly(P-value<0.001). Also, 2, 4, 6, and 8 hours after surgery, mean pain intensity among IN group was significantly lower than the IV group. Mean 48-hours pain intensity in the IN group was significantly lower than the IV group (P-value<0.05). In the IN group, dose of antinociceptive medicine was slightly higher and the time to request it was shorter than the other group. However, t-test for independent groups showed that this finding was not statistically significant (P-value>0.05). Conclusion: The application of intranasal Ketorolac spray reduces the pain after mandibular fracture surgery, especially at first 8 hours after the surgery and reduces the need to opioid medicines.