Phase 4
N=119
Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT02025634 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Postoperative Pain Levels — 1.3160; 2.1362 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intravenous Acetaminophen (Drug); Placebo (0.9% Normal Saline infusion) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AdventHealth
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain Levels |
1.3160; 2.1362 | — |
| SECONDARY Postoperative Opioid Consumption |
3; 2 | — |
Summary
The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.
Eligibility Criteria
Inclusion Criteria
- Is scheduled for knee arthroscopy with or without chondroplasty.
- Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures.
- Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery.
- Is willing and able to sign an informed consent.
Exclusion Criteria
- Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures
- Has self-reported and/or documented previous hypersensitivity to acetaminophen.
- Has self-reported and/or documented history of hepatic disease or impairment.
- Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.
- Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day.
- Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment of the physician PI/Sub-I.
Data sourced from ClinicalTrials.gov (NCT02025634). 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.