Phase 4
Completed N=27
The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy
Source: ClinicalTrials.gov NCT03445390 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Post-operative Opioid Consumption — 228; 312 ug
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to determine the efficacy of IV acetaminophen when administered to neurosurgical patients at the beginning and end of their surgery. If the result is improved pain control with less opioid consumption postoperatively, then those patients may also experience less opioid related side effects such as nausea/vomiting, pruritus, and sedation. While numerous other studies have failed to show a benefit of IV acetaminophen after neurosurgical procedures, we are studying the administration of 1 g in two doses over the course of the operation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Opioid Consumption |
228; 312 | — |
| PRIMARY Post-operative Pain |
3.4; 3.8; 2.7; 2.6; 3.1; 3.2 | — |
| SECONDARY Count of Participants Requiring Anti-emetic Administration |
20; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral external-carotid to internal-carotid bypass surgery to be done in two stages.
Exclusion Criteria
- Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone not able to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT03445390). 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.