A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2013 |
| Contact: | Amy McCoart |
| Email: | amccoart@dvpmi.org |
| Phone: | 910-907-6239 |
The purpose of the study is to learn whether perioperative IV (intravenous) administration
of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes
over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic
cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen,
it may result in fewer requests for pain-related intervention such as other oral pain
medications.
of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes
over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic
cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen,
it may result in fewer requests for pain-related intervention such as other oral pain
medications.
Inclusion Criteria:
- Male and female patients ASA I - III (A system used by anesthesiologists to stratify
severity of patients' underlying disease and potential for suffering complications
from general anesthesia ), 18 years of age and older
- Patient must be scheduled for laparoscopic cholecystectomy
Exclusion Criteria:
- Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous
abdominal surgery
- Chronic home narcotic use (patient-reported narcotic use for greater than 3 months)
- Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs
closest to surgical date or within 6 months prior to surgery
- Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to
surgical date or within 6 months prior to surgery
- Open or emergency surgery (non-scheduled surgery, surgery that must be performed
within 6 hours for this particular surgery)
- Prior NSAIDS(Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within
the last 24 hours
- Use of intraoperative NSAIDs
- Contraindication to study drug (including allergic reaction or hypersensitivity to
acetaminophen or any of its components;
- On a medication with known interactions with acetaminophen
- On chronic oral acetaminophen, greater than 6 months on a daily basis at a dose
greater than 3000mg/day
- Pregnancy
- Current or past alcohol abuse (within the past 2 years)
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