Purpose

Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.

Condition

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age equal to 65 or greater
  2. Pain onset within 7 days with severe pain
  3. Has capacity to provide informed consent
  4. Understanding English or Spanish

Exclusion Criteria

  1. Use of tramadol or opioids within 7 days
  2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
  3. Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
  4. Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
  5. Alcohol intoxication
  6. Systolic blood pressure: < 100 mmHg
  7. Heart rate: < 60 beats per minute
  8. Oxygen saturation: < 95% on room air
  9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days
  10. Use of transdermal pain patch or oral opioid > 10 days in the prior month
  11. Prior enrollment in the same study

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acetaminophen 1000mg IV
NRS pain scores will be obtained at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes.
  • Drug: Acetaminophen 1000mg IV
    1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push
Active Comparator
Hydromorphone 0.5mg IV
NRS score will be checked at 5 minutes and every 15 minutes for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes.
  • Drug: Hydromorphone 0.5 mg IV
    100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Benjamin W Friedman
718-920-6626
befriedm@montefiore.org

More Details

NCT ID
NCT03521102
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Alexander V Latev, MD
4254437245
alatev@montefiore.org

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.