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A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

Information source: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Laparoscopic Cholecystectomy

Intervention: 2 capsules Oral Tylenol 2000 mg and IV "salt water" (Drug); IV tylenol 1000mg and 2 oral capsule "sugar pills" (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Defense and Veterans Center for Integrative Pain Management

Overall contact:
Amy McCoart, Phone: 910-907-6239, Email: amccoart@dvpmi.org

Summary

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.

Clinical Details

Official title: A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Primary outcome: Pain

Secondary outcome: Opioid Use

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Amy McCoart, Phone: 910-907-6239, Email: amccoart@dvpmi.org

Womack Army Medical Center, Fort Bragg, North Carolina 28310, United States; Recruiting
Additional Information

Starting date: February 2013
Last updated: December 31, 2014

Page last updated: August 23, 2015

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