Recruiting

IV vs. PO Acetaminophen

Sponsor:

Thomas Jefferson University

Code:

NCT02067442

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

oral acetaminophen

intravenous acetaminophen

Study Details

Brief summary:

Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores or decrease opioid consumption during the first postoperative day compared to the oral formulation.

Conditions

Pain

Study ID

NCT02067442

Start date

Aug, 2013

Status verified date

Mar, 2015

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Single level lumbar micro disk surgery
  • Ages 18-65

Exclusion Criteria

  • morbid obesity
  • prior back surgery
  • opioid tolerance
  • pregnancy

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: oral acetaminophen

Patients in this arm of the study will receive oral acetaminophen and an IV placebo

active comparator: intravenous acetaminophen

Patients in this arm of the study will receive IV acetaminophen and an oral placebo

Interventions

oral acetaminophen

1000 milligrams given orally before surgery

intravenous acetaminophen

1000 milligrams of intravenous acetaminophen given before surgery

Primary outcome measure

  • Postoperative pain scores [ Time Frame: Day of surgery ]

Central Contacts and Locations

Central contacts

Marc D Fisicaro, MD

215-955-6161marc.fisicaro@jefferson.edu

Locations

Thomas Jefferson University Hopsital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Marc Fisicaro, MD

marc.fisicaro@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 18, 2015

Last verified

Mar, 2015

Keywords

  • acetaminophen intravenous oral pain scores opioids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2015-03-18.