Recruiting

IV vs. PO Acetaminophen

Sponsor:

Main Line Health

Code:

NCT04290208

Conditions

Postoperative Pain

Cesarean Section

Acetaminophen

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Acetaminophen

Acetaminophen

Placebos

Placebos

Study Details

Brief summary:

This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section.

Conditions

Postoperative Pain

Cesarean Section

Acetaminophen

Study ID

NCT04290208

Start date

Aug 22, 2019

Status verified date

Feb, 2020

Completion date

Jun 23, 2020

Anticipated

Primary completion date

Jun 23, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Women age 18 or older
  • Scheduled to undergo a cesarean section

Exclusion Criteria:

  • Existing diagnosis of chronic pain
  • Need to undergo a vertical skin incision
  • Aspartate Aminotransferase (AST) > 50, alanine aminotransferase (ALT) > 70
  • Platelets below 80,000 on admission
  • Need to undergo general anesthesia
  • Tubal ligation at time of Cesarean section
  • Prior or known allergy to any of the medications being utilized in this study

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intravenous Administration of Acetaminophen

A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed.

active comparator: Per Oral Administration of Acetaminophen

A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room.

Interventions

Acetaminophen

IV Acetaminophen

Acetaminophen

Acetaminophen liquid syrup

Placebos

Flavored, non-medicated (placebo) liquid syrup

Placebos

IV salt solution (non-medicated)

Primary outcome measure

  • Narcotic Utilization [ Time Frame: 6 hours post operative ]

Central Contacts and Locations

Central contacts

Dmitri Chamchad, MD

610-355-9451chamchad@hotmail.com

Locations

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Derek Bowden

484-476-2692Dbowden@mlhs.org

More Information

Sponsor

Main Line Health

Last update posted

Feb 28, 2020

Last verified

Feb, 2020

Keywords

  • Humans
  • Female
  • Pregnancy
  • Acetaminophen
  • Narcotics
  • Patient Satisfaction
  • Cesarean Section
  • Pain
  • Postoperative Period

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Main Line Health on 2020-02-28.