RECRUITING

Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Adult patients with morbid obesity who have had Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG) surgery have impaired drug metabolism. There is a paucity of information available on how these patients metabolize acetaminophen post operatively and if drug preparation has any effect on achieving adequate pain control. The surgery may alter the stomach pH, reduce surface area of the stomach, affect transit time, and alter anatomic and physiologic standard absorption of medications. Due to these anatomic and physiologic changes, we seek to understand the potential effects of liquid versus pill formulations of acetaminophen on pain control in this patient population. The purpose of this study is to assess for subjective and objective measures of optimized pain control between formulations of acetaminophen including oral pills and oral liquid.

Official Title

Comparative Efficacy of Two Different Oral Dosage Forms of Acetaminophen for Post-operative Analgesia in Bariatric Surgery Patients

Quick Facts

Study Start:2024-11-13
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06658574

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18 years old or greater who meet patient selection criteria for either primary Roux-en-Y gastric bypass or primary laparoscopic sleeve gastrectomy.
  1. * Patients with a known hypersensitivity or history of intolerance to acetaminophen or any inactive ingredients in either formulation. Patients uncomfortable with or unable to take pills.
  2. * Surgical: Duodenal Switch (DS) surgeries, Adjustable Gastric Banding (AGB), surgical revisions, and surgical conversions.
  3. * Medical: patients with documented history of chronic and/or current pain syndrome, as evidenced by documentation of ICD-10 code G89.4, patients with documented ICD-10 code F11.90, indication unspecified, uncomplicated opioid use.
  4. * Patients of vulnerable populations, as outlined by federal guidelines as children, prisoners, pregnant women, and mentally disabled persons will be excluded.

Contacts and Locations

Study Contact

Daniel T Abazia, PharmD
CONTACT
773-633-5215
dabazia@pharmacy.rutgers.edu
Mae Zoltowsky, BSN
CONTACT
Mae.Zoltowsky2@rwjbh.org

Principal Investigator

Daniel T Abazia, PharmD
PRINCIPAL_INVESTIGATOR
Rutgers University - Ernest Mario School of Pharmacy

Study Locations (Sites)

Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08690
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Daniel T Abazia, PharmD, PRINCIPAL_INVESTIGATOR, Rutgers University - Ernest Mario School of Pharmacy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-13
Study Completion Date2025-03

Study Record Updates

Study Start Date2024-11-13
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Acetaminophen
  • Bariatric
  • Analgesia
  • Perioperative
  • Post Operative

Additional Relevant MeSH Terms

  • Post Operative Analgesia
  • Bariatric Surgery
  • Bariatric Surgery (Gastric Bypass)
  • Bariatric Surgery Patients
  • Perioperative Analgesia