NCT03553498

IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

Randomized Clinical Trial of IV Acetaminophen as an Adjuvant Analgesic to IV Hydromorphone for Treatment of Acute Severe Pain in Non-Elderly Emergency Department Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized clinical trial is to compare the analgesic efficacy and side effect profile of IV acetaminophen as an analgesic adjunctive medication to IV hydromorphone for the treatment of acute pain experienced by patients in the Emergency Department (ED).

Detailed description

Multimodal treatment of pain is a commonly used strategy to control pain by combining analgesics with different and complementary mechanisms of action. Oral acetaminophen combined with opioids is a mainstay of treatment of mild to moderate pain, while the use of IV opioids is the standard for treatment of severe pain in the Emergency Department. An IV formulation of acetaminophen is widely used in Europe and has recently been approved in the US. It has been studied for treatment of acute post-operative pain and renal colic. This randomized trial was designed to assess the effectiveness of the combination of IV acetaminophen and IV hydromorphone as a strategy to provide more effective treatment of acute severe pain in the Emergency Department with the possibility of reducing opioid consumption. All patients received 1 mg of IV hydromorphone. They were then randomized to receive either 1 g of IV acetaminophen or 100 mL of normal saline placebo. Measures of pain, vital signs, and presence of side effects were obtained immediately before IV hydromorphone was administered. Following receipt of the acetaminophen or placebo these same variables were measured at 15 minute intervals for the next 120 minutes. Additional analgesics were administered if patients requested them. Subsequent care of the patients was at the discretion of the treating attending physician.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	IV acetaminophen	acetaminophen given intravenously
DRUG	IV placebo	given intravenously
DRUG	hydromorphone	hydromorphone given intravenously

Timeline

• Start date: 2018-11-27
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2018-06-12
• Last updated: 2022-03-02
• Results posted: 2022-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study