IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

NCT03553498 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2018-8886
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Pain

Keywords

pain; opioid analgesics; Emergency Department; randomized controlled trial; acetaminophen; hydromorphone

Outcome Measures

Primary Outcomes (1)

• Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment

  The between group difference in change in NRS pain scores from before administration of study medications to 60 minutes post administration of study medications. The NRS is a previously validated and reproducible measure of pain intensity ranging from 0 = no pain, to 10 = worst possible pain. Higher values indicate more pain relief from before treatment to 60 minutes after treatment

  Before treatment to 60 minutes after treatment

Secondary Outcomes (3)

• Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication

  Baseline to 60 minutes post-baseline

• Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications

  61 to 120 minutes post-baseline

• Percentage of Patients Who Want Additional Analgesics

  Immediately after administration of study medication to 120 minutes after administration of study medication

Study Arms (2)

IV hydromorphone and IV acetaminophen

EXPERIMENTAL

1000 mg IV acetaminophen administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes

Drug: IV acetaminophen; Drug: hydromorphone

IV hydromorphone and placebo

PLACEBO COMPARATOR

100 ml IV normal saline administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes

Drug: IV placebo; Drug: hydromorphone

Interventions

IV acetaminophen DRUG

acetaminophen given intravenously

Also known as: Ofirmev

IV hydromorphone and IV acetaminophen

IV placebo DRUG

given intravenously

Also known as: normal saline

IV hydromorphone and placebo

hydromorphone DRUG

hydromorphone given intravenously

Also known as: Dilaudid

IV hydromorphone and IV acetaminophen; IV hydromorphone and placebo

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain; Emergencies

Interventions

Acetaminophen; Saline Solution; Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; 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

Results Point of Contact

• Title: Polly Bijur
• Organization: Albert Einstein College of Medicine

polly.bijur@einsteinmed.org

718-430-4217

Study Officials

• Polly Bijur

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine, Epidemiology and Population Health, and of Pediatrics

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 12, 2018
• Study Start: November 27, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)