Key result
Ketorolac after elective neurosurgery shows no link to increased risk of intracranial hemorrhage requiring surgery.
Why the study?
The safety of ketorolac regarding bleeding risk has been demonstrated in general surgery, but comparable safety data for neurosurgical patients were lacking.
Does ketorolac increase the risk of postcraniotomy intracranial hemorrhage requiring surgery in patients undergoing elective neurosurgical procedures?
Cohort (n=4,086)
Does ketorolac increase the risk of postcraniotomy intracranial hemorrhage requiring surgery in patients undergoing elective neurosurgical procedures?
Odds Ratio: 1.09 (95% CI 0.35–3.44)
Absolute Event Rate: 0.5% vs 1.3%
p-value: p=0.88
Ketorolac use after elective neurosurgery did not show a statistically significant increase in the risk of symptomatic intracranial hemorrhage requiring surgery, though wide confidence intervals preclude definitive conclusions on safety.
Ketorolac may not increase postcraniotomy ICH risk in elective cases; leaves open definitive safety assessment pending larger prospective trials.
BACKGROUND: Ketorolac tromethamine (ketorolac) is a nonsedating drug with potent analgesic and moderate anti-inflammatory activity, which does not increase the sedation level. The safety of ketorolac with respect to risk of bleeding has been demonstrated in large numbers of patients undergoing general surgery, yet comparable safety data for neurosurgical patients are lacking. We studied the risk of symptomatic bleeding requiring surgery in patients undergoing elective neurosurgical procedures who received ketorolac as analgesic therapy. METHODS: We established a cohort of patients who had elective intracranial procedures from January 2001 to August 2010 (excluding patients with urgent surgery, coagulopathy, history of anticoagulant or nonsteroidal, anti-inflammatory drug therapy) and verified the occurrence of postcraniotomy intracranial hemorrhage (ICH; detected by computed tomography and requiring surgery) in patients who received or did not receive ketorolac. Then, to control for potential confounders, we conducted a "nested" case-control study within the cohort: cases were defined as patients with ICH; controls were patients without ICH matched in a 2:1 ratio. RESULTS: The cohort included 4086 craniotomy patients (mean age, 52.4±14.3 years, 2124 male, 52%). Of the 1571 patients who received ketorolac (mean dosage, 50±15 mg/d), 8 (0.5%) suffered ICH; of the 2515 patients who did not receive ketorolac, 35 (1.3%) had ICH (relative risk, 0.37; 95% confidence interval, 0.17-0.79; P=0.007). In the nested case-control study, the adjusted odds ratio for ketorolac administration between the 2 groups was 1.09 (95% confidence interval, 0.35-3.44; P=0.88). CONCLUSION: Although the adjusted estimate for risk of symptomatic bleeding requiring surgery and ketorolac use is very close to the null effect, it may be not reproducible, and the width of the confidence interval is not conclusive evidence of the safety of ketorolac after elective neurosurgical procedures.
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Magni et al. (2013) conducted a cohort in Elective neurosurgical procedures (n=4,086). Ketorolac vs. No ketorolac was evaluated on Postcraniotomy intracranial hemorrhage requiring surgery (OR 1.09, 95% CI 0.35-3.44, p=0.88). Ketorolac use after elective neurosurgery was not significantly associated with increased risk of intracranial hemorrhage requiring surgery (adjusted OR 1.09; 95% CI 0.35-3.44; P=0.88).
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