Background: Patients admitted for nonsurgical management of small bowel obstruction (SBO) often receive intravenous (IV) opioids for pain relief. However, given the opioid crisis and the potential for opioids to hinder recovery and contribute to ileus, exploring alternative analgesics is crucial. This randomized controlled trial (RCT) evaluates the efficacy of IV acetaminophen for pain management in SBO patients, focusing on its impact on pain control, complications, recovery, hospital stay, and 30-day post-discharge mortality.
Methods: This double-blind, prospective, randomized, placebo-controlled trial aimed to assess the safety and efficacy of IV acetaminophen in patients with SBO. Conducted at Mayo Clinic Jacksonville from September 4, 2023, to October 4, 2024, the study involved 18 patients who were randomly assigned to either the acetaminophen or placebo group. All participants received additional pain medications (IV morphine, hydromorphone, or tramadol) at the attending physician’s discretion. The treatment group received 1 g IV acetaminophen every 6 hours for 2 days and every 8 hours on day 3, while the placebo group received normal saline at the same schedule. The trial was discontinued after 3 days or upon resolution of SBO. Pain levels were measured using a subjective scale (0–10), and opioid consumption was converted to morphine milligram equivalents (MME). Primary objectives were to assess the trial’s feasibility, pain scores, opioid use, time to resolution of SBO, hospital stay, and 30-day mortality. Secondary endpoints included complications like bowel perforation, surgical interventions, and adverse reactions. Chronic opioid users were excluded.
Results: The two groups were similar in demographics and clinical characteristics, including age (67 vs. 68 years, p = 0.351), sex (p = 0.637), ethnicity (p = 1.0), and SBO type (complete vs. partial, p = 1.0). One patient in the treatment group required surgery, while one in the placebo group needed a venting tube. No cases of bowel perforation, allergic reactions, delirium, or naloxone use were reported. Pain scores tended to be lower in the treatment group on day 1 (2.8 vs 4.2, p = 0.271), day 2 (3.5 vs 4.2, p = 0.902), and day 3 (5 vs 2.1, p = 0.54). The total MME administered in the ED before study entry was similar between groups (18.3 vs. 19.2, p = 0.471). However, MME use during the study was lower in the treatment group (9.1 vs. 17.3, p = 0.833). Hospital stays were slightly shorter in the treatment group (median 3 days vs. 5 days, p = 0.129), and the time to resolution of SBO was also reduced (1 day vs. 2 days, p = 0.061).
Conclusions: While statistical significance was not achieved—likely due to the small sample size—the treatment group showed trends toward lower opioid consumption, shorter hospital stays, and quicker SBO resolution. Larger studies are needed to confirm these findings and further evaluate IV acetaminophen’s role in reducing opioid use, improving patient safety, and minimizing opioid-related adverse effects.