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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06658574
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acetaminophen — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Apr 2025
Primary completion
Feb 28, 2026
Completion
May 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral acetaminophen - Tablet
    Acetaminophen 650 mg tablet by mouth
  • Experimental: Oral acetaminophen - Liquid
    Acetaminophen 650 mg liquid by mouth

Primary Outcome Measure

Pain control [ Time Frame: From date of consent until the date of hospital discharge, assessed up to 3 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Robert Wood Johnson University HospitalNew BrunswickNew Jersey08690
Daniel Abazia, PharmD, BCPS, CPPS
[email protected]
773-633-5215
Mindy Rodden, PhD, RN, CPNP-AC
[email protected]
732-418-8078

Find similar trials in New Brunswick, NJ

By research site
Robert Wood Johnson University Hospital· New Brunswick, NJ

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