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Phase 4 Completed N=210 Randomized Triple-blind Treatment

Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Post-operative Craniotomy Patients · Carotid Endarterectomy and Carotid Artery Stenosis Patients · Post-op Spine Patients Admitted to the NCCU · Endovascular Patients Undergoing Intracranial Intervention
Source: ClinicalTrials.gov NCT01948505 ↗
Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Narcotic Requirement After Surgery — 123.5; 134.2 Morphine Equivalents
◆ Published Evidence
Established
29citations · ~4 / year
Intravenous acetaminophen for postoperative supratentorial craniotomy pain: a prospective, randomized, double-blinded, placebo-controlled trial.
Journal of neurosurgery · 2019 · Open access · Likely link

Summary

To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain. To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients. To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.

Linked Publications

  • Intravenous acetaminophen for postoperative supratentorial craniotomy pain: a prospective, randomized, double-blinded, placebo-controlled trial.
    Journal of neurosurgery · 2019 · 29 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Narcotic Requirement After Surgery
123.5; 134.2

Eligibility Criteria

Inclusion Criteria

  • > 45 kg (amenable to adult dosing)
  • all traumatic brain injuries NPO for at least 12 hours
  • all post-operative craniotomy patients
  • all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients
  • all carotid endarterectomy and carotid artery stenosis patients
  • all endovascular patients undergoing intracranial intervention
  • all post-op spine patients admitted to the NCCU

Exclusion Criteria

  • documented allergy to acetaminophen
  • documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
  • documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.
  • patients who are pregnant or breast feeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01948505) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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