Phase 4
N=100
Intravenous Acetaminophen in Craniotomy
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01598701 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Post-Operative Opioid Requirement — 11.0; 10.1 Morphine Equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acetaminophen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Operative Opioid Requirement |
11.0; 10.1 | — |
| SECONDARY Post-Operative Pain |
1.4; 2.6; 6.3; 6.4 | — |
| SECONDARY Post-Operative Side Effects |
23; 20; 8; 5; 14; 14 | — |
| SECONDARY Time to Extubation at Emergence From Anesthesia |
6; 8 | — |
| SECONDARY Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria |
11.4; 13.5 | — |
Summary
The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an effective adjunct therapeutic agent in patients undergoing craniotomy.
Eligibility Criteria
Inclusion Criteria
- Adults
- Undergoing Craniotomy for Supratentorial Tumor Resection
- Weight between 50 and 120 kilograms
- ASA Physical Status I-III
- Be able to communicate verbally
- Be able to use Visual Analog Score
Exclusion Criteria
- Allergies to acetaminophen, morphine or any of the anesthetic agents required by the protocol.
- Use of opioids, tramadol, benzodiazepines, or gabapentin on a daily basis for > 7 days prior to the day of surgery.
- Use of acetaminophen, NSAIDs, or any other analgesic medication in the 12 hours immediately prior to study enrollment.
- Hepatic insufficiency (elevated transaminases > 1.5 times the upper limit of normal) or renal insufficiency (plasma creatinine > 2mg/dl).
- Known or suspected history of alcohol or illicit drug abuse.
- Pregnant or breast-feeding.
- Surgical plan for infratentorial (suboccipital) craniotomy.
- Plan for neurophysiologic monitoring that precludes the use of neuromuscular blockade.
- Inability to communicate due to a language barrier, impaired consciousness, cognitive defect or intellectual disability.
- Uncontrolled Hypertension
Data sourced from ClinicalTrials.gov (NCT01598701). 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.