Effect of a Single Preventive Intravenous Dose of Ketorolac and Paracetamol on Reducing Postoperative Pain in Septorhinoplasty Patients: Double-Blind Randomized Clinical Trial

Abstract

Background: Effective pain management is crucial in septorhinoplasty and remains a significant challenge. This study investigated the effect of ketorolac and paracetamol on pain control in septorhinoplasty patients and assessed their efficacy in reducing the need for rescue analgesics.

Methods: This double-blind randomized clinical trial was conducted at Madar-Koodak Hospital (Shiraz, Iran), in 2022. Ninety-nine patients were randomly assigned to three groups to receive ketorolac 30 mg (n=33), paracetamol 1000 mg (n=33), and normal saline (n=33), respectively. All the medications were administered intravenously (IV) 30 min before surgery. The randomization procedure followed the block randomization method. If the pain did not subside, patients were also given a single dose of pethidine hydrochloride (25 mg). Pain intensity was measured using visual analog scale (VAS) 1 hour and 6 hours after surgery. The data were analyzed using SPSS software, using paired t tests, ANOVA, and Chi square tests.

Results: One-hour post-surgery, VAS scores in the ketorolac and paracetamol groups were significantly lower than in the placebo group (P<0.001). The mean difference with 95% CI for ketorolac-placebo and paracetamol-placebo was -0.57 (-0.94, -0.21), and -0.79 (-1.12, -0.45), respectively. The ketorolac and paracetamol groups required significantly less pethidine hydrochloride 1 hour post-surgery than the placebo group (P<0.001). The VAS scores and requiring pethidine were not significantly different between the ketorolac and paracetamol groups.

Conclusion: After septorhinoplasty, the administration of 1000 mg of IV paracetamol demonstrated comparable efficacy in pain reduction to 30 mg of ketorolac. It suggested that paracetamol could serve as a viable alternative to ketorolac in preventing postoperative pain after septorhinoplasty, particularly in patients for whom non-steroidal anti-inflammatory (NSAID) drugs could not be a suitable choice.Trial Registration Number: IRCT20180922041084N6.

Keywords: Acetaminophen; Analgesia; Pain management; Rhinoplasty.

Figure 1

This figure represents the CONSORT flow diagram of the study.