Intracranial hemorrhage requiring surgery in neurosurgical patients given ketorolac

A case-control study within a cohort (2001-2010)

Giuseppina Magni, Italia La Rosa, Guido Melillo, Damiano Abeni, Helssy Hernandez, Giovanni Rosa

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)443-447
Number of pages5
JournalAnesthesia and Analgesia
Volume116
Issue number2
DOIs
Publication statusPublished - Feb 2013

Fingerprint

Ketorolac
Intracranial Hemorrhages
Case-Control Studies
Neurosurgical Procedures
Confidence Intervals
Hemorrhage
Safety
Ketorolac Tromethamine
Craniotomy
Non-Steroidal Anti-Inflammatory Agents
Anticoagulants
Analgesics
Anti-Inflammatory Agents

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

Cite this

Intracranial hemorrhage requiring surgery in neurosurgical patients given ketorolac : A case-control study within a cohort (2001-2010). / Magni, Giuseppina; La Rosa, Italia; Melillo, Guido; Abeni, Damiano; Hernandez, Helssy; Rosa, Giovanni.

In: Anesthesia and Analgesia, Vol. 116, No. 2, 02.2013, p. 443-447.

Research output: Contribution to journalArticle

@article{a977000710284ef0b9646cd14b728637,
title = "Intracranial hemorrhage requiring surgery in neurosurgical patients given ketorolac: A case-control study within a cohort (2001-2010)",
abstract = "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.",
author = "Giuseppina Magni and {La Rosa}, Italia and Guido Melillo and Damiano Abeni and Helssy Hernandez and Giovanni Rosa",
year = "2013",
month = "2",
doi = "10.1213/ANE.0b013e3182746eda",
language = "English",
volume = "116",
pages = "443--447",
journal = "Anesthesia and Analgesia",
issn = "0003-2999",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - Intracranial hemorrhage requiring surgery in neurosurgical patients given ketorolac

T2 - A case-control study within a cohort (2001-2010)

AU - Magni, Giuseppina

AU - La Rosa, Italia

AU - Melillo, Guido

AU - Abeni, Damiano

AU - Hernandez, Helssy

AU - Rosa, Giovanni

PY - 2013/2

Y1 - 2013/2

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84872869288&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84872869288&partnerID=8YFLogxK

U2 - 10.1213/ANE.0b013e3182746eda

DO - 10.1213/ANE.0b013e3182746eda

M3 - Article

VL - 116

SP - 443

EP - 447

JO - Anesthesia and Analgesia

JF - Anesthesia and Analgesia

SN - 0003-2999

IS - 2

ER -