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

NCT03521102 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2018-8876
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement in NRS Pain Score

  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.

  60 minutes following administration of medication

Secondary Outcomes (2)

• Need for Rescue Medication

  120 minutes following administration of medication

• Improvement in NPS Pain Score by >=50%

  60 minutes after administration of medication

Study Arms (2)

Acetaminophen 1000mg IV

EXPERIMENTAL

NRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 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

Hydromorphone 0.5mg IV

ACTIVE COMPARATOR

NRS pain score will be checked at 5 minutes and every 15 minutes thereafter 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

Interventions

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

Acetaminophen 1000mg IV

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

Hydromorphone 0.5mg IV

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Kolli S, Friedman BW, Latev A, Chang AK, Naeem F, Feliciano C, Afrifa F, Walker C, Izzo A, Irizarry E. A Randomized Study of Intravenous Hydromorphone Versus Intravenous Acetaminophen for Older Adult Patients with Acute Severe Pain. Ann Emerg Med. 2022 Nov;80(5):432-439. doi: 10.1016/j.annemergmed.2022.06.016. Epub 2022 Aug 12.

  PMID: 35965162 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Acetaminophen; Hydromorphone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Enrollment limited to 2 urban EDs, excluding a large number of patients who had been screened. Results may not be generalizable to all older patients with acute severe pain Dose ranging studies were not conducted to help optimize hydromorphone dosage An arbitrary value (1.3) was selected as the minimum clinically important improvement threshold The study relied on the clinical attending physician's judgment of whether opioids were indicated. Would not account for local practices

Results Point of Contact

• Title: Dr. Benjamin Friedman
• Organization: Montefiore Medical Center

bfriedm@montefiore.org

718-920-6626

Study Officials

• Benjamin Friedman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 11, 2018
• Study Start: August 20, 2018
• Primary Completion: October 30, 2021
• Study Completion: March 23, 2022
• Last Updated: March 2, 2023
• Results First Posted: March 2, 2023

Record last verified: 2023-02

Locations

US (1)