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Clinical Trial
. 2025 Apr 1;50(4):239-246.
doi: 10.30476/ijms.2024.102131.3488. eCollection 2025 Apr.

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

Laleh Dehghanpisheh  1 , Fatane Jamshidi  1 , Saeid Khademi  1 , Shirin Farokhiani  1 , Mohammad Reza Cheraghi  2 , Mahsa Emadi  1 , Reza Kaboodkhani  3 , Ali Akbari  1 , Naeimehossadat Asmarian  1 , Mahsa Banifatemi  1
Affiliations
Clinical Trial

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

Laleh Dehghanpisheh et al. Iran J Med Sci. .

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.

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Conflict of interest statement

Naeimehossadat Asmarian, as the Editorial Board Member, was not involved in any stage of handling this manuscript. A team of independent experts was formed by the Editorial Board to review the article without her knowledge.

Figures

Figure 1
Figure 1
This figure represents the CONSORT flow diagram of the study.
See this image and copyright information in PMC

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