Comparing the efficacy of combining ketorolac and Paracetamol (Acetaminophen) with Paracetamol alone on postoperative pain after laminectomy. A double-blinded randomized clinical trial.

BACKGROUND

Postoperative pain management has driven a shift toward non-opioid analgesics. Combining Paracetamol (Acetaminophen) and Ketorolac, a multimodal analgesic approach shows potential. However, evidence on the synergistic effects of these combinations remains limited, particularly for laminectomy.

METHODS

This randomized, double-blinded controlled trial was conducted between March 2023 and December 2024. Eligible patients were adults undergoing laminectomy who met the inclusion and exclusion criteria. Participants were randomized to receive either conventional Paracetamol (1000 mg) with or without Ketorolac (30 mg) every 6 h for 24 h. Primary outcomes included postoperative morphine consumption and pain intensity measured by the Visual Analogue Scale (VAS). Secondary outcomes included hemodynamic changes and the incidence of postoperative nausea and vomiting (PONV).

RESULTS

A total of 90 patients completed the study, with comparable baseline demographics between groups. The intervention group required significantly less morphine (0.35 ± 0.95 mg) compared to the control group (1.33 ± 3.03 mg) in the first 24 h post-surgery (p = 0.02). Pain intensity decreased over time in both groups, with no significant differences observed in VAS scores. Hemodynamic parameters were more stable in the intervention group, with lower systolic and diastolic blood pressures over time; however, some results were not statistically significant. The incidence of PONV was similar between groups.

CONCLUSIONS

While the combination therapy demonstrated trends toward improved hemodynamic stability, some parameters, such as DBP and MAP, did not reach statistical significance, warranting further exploration. Further research is recommended to validate the broader applicability of this combination in various surgical contexts.

TRIAL REGISTRATION: The study was registered at irct.behdasht.gov.ir/trial/66,286 (IRCT20221010056140N1, registration date: 01/28/2023).