Actively Recruiting
Comparative Efficacy of Two Different Oral Dosage Forms of Acetaminophen for Post-operative Analgesia in Bariatric Surgery Patients
Led by Rutgers, The State University of New Jersey · Updated on 2025-04-02
150
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
R
Rutgers Robert Wood Johnson Medical School
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
- Surgical: Duodenal Switch (DS) surgeries, Adjustable Gastric Banding (AGB), surgical revisions, and surgical conversions.
- 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.
- Patients of vulnerable populations, as outlined by federal guidelines as children, prisoners, pregnant women, and mentally disabled persons will be excluded.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08690
Actively Recruiting
Research Team
D
Daniel T Abazia, PharmD
M
Mindy Rodden, PhD, RN, CPNP-AC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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