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Completed

NCT Number: NCT03521102

Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age equal to 65 or greater
  • Pain onset within 7 days with severe pain
  • Has capacity to provide informed consent
  • Understanding English or Spanish

Exclusion criteria

  • Use of tramadol or opioids within 7 days
  • Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
  • Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
  • 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
  • Alcohol intoxication
  • Systolic blood pressure: < 100 mmHg
  • Heart rate: < 60 beats per minute
  • Oxygen saturation: < 95% on room air
  • Use of monoamine oxidase (MAO) inhibitors in the past 30 days
  • Use of transdermal pain patch or oral opioid > 10 days in the prior month
  • Prior enrollment in the same study

Treatment and study plan

Acetaminophen 1000mg IV

Drug

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

Hydromorphone 0.5 mg IV

Drug

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

Primary outcomes

  1. Clinical Improvement in NRS Pain Score

    Time frame: 60 minutes following administration of medication

    Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale.

Secondary outcomes

  1. Need for Rescue Medication

    Time frame: 120 minutes following administration of medication

    Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.

  2. Improvement in NPS Pain Score by >=50%

    Time frame: 60 minutes after administration of medication

    The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 11, 2018
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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