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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 21 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pain with onset within 7 days of the ED visit - ED attending physician's judgment that the patient's pain warrants IV opioids. - ED attending physician's judgment that the patient has capacity to provide informed consent. - ED attending physician's judgement that patient is not a chronic user of opioids or acetaminophen - Patients must be able to understand English or Spanish.

Exclusion Criteria

  • Use of opioids or tramadol within past 24 hours. - Use of acetaminophen or non-steroidal anti-inflammatory medication within the previous 8 hours. - Prior adverse reaction to opioids or acetaminophen. - Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months; examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. - Medical condition that might affect metabolism or opioid analgesics or acetaminophen such as hepatitis, renal insufficiency or failure, hypo- or hyper-thyroidism, Addison's or Cushing's disease - Pregnant or breastfeeding - Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician or nurse - Not at risk of suicide assessed by triage nurse - Systolic blood pressure <100 mmHg - Heart Rate < 60/min - Oxygen saturation < 95% on room air: - Use of monoamine oxidase (MAO) inhibitors in past 30 days - Use of transdermal pain patches - Taking any medication that might interact with one of the study medications, such as a selective serotonin reuptake inhibitor (SSRI) or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine or St. John's Wort. - Patients who have been previously enrolled in this same study

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized Clinical Trial
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The pharmacist working in an area inaccessible to ED staff will ensure blinding by creating identical vials containing either 1000 mg acetaminophen in 100 ml normal saline or 100 ml normal saline placebo and numbering them sequentially for use in this study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IV hydromorphone and IV acetaminophen 		1000 mg IV acetaminophen administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes
  • Drug: IV acetaminophen
    acetaminophen given intravenously
    Other names:
    • Ofirmev
  • Drug: hydromorphone
    hydromorphone given intravenously
    Other names:
    • Dilaudid
Placebo Comparator
IV hydromorphone and placebo 		100 ml IV normal saline administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes
  • Drug: IV placebo
    given intravenously
    Other names:
    • normal saline
  • Drug: hydromorphone
    hydromorphone given intravenously
    Other names:
    • Dilaudid

More Details

Status
Completed
Sponsor
Albert Einstein College of Medicine

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.