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RECRUITING
NCT06658574
PHASE2

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

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-11-13

Completion Date

2026-05

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

DRUG

Acetaminophen

Arm 1: Once cleared for oral intake - acetaminophen tablets 650 mg PO every 6 hours PRN - mild pain (1 - 3) to a maximum of 4 grams daily for 3 days\' dispensed as unit-dose tablets Arm 2: Once cleared for oral intake - acetaminophen liquid (160 mg/5 mL) 650 mg PO every 6 hours PRN - mild pain (1 - 3) to a maximum of 4 grams daily for 3 days; 650 mg = 20.3 mL, dispensed as a unit-dose cup

Locations (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States