Comparing Intravenous Hydromorphone to Usual Care

NCT01429298 | Completed Phase 4 Results

• 1 other identifier: MMC 09-11-346
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized controlled trial, 2 mg intravenous (IV) hydromorphone will be more efficacious than usual care (usual care is analgesic management according to the judgment of the attending physician caring for that patient) in emergency department (ED) patients aged 21-64 years. The primary efficacy outcomes are the proportion of patients in each arm who choose to forgo additional pain medication in 30 minutes of entry into the study and the change in numerical rating scale (NRS) pain scores from baseline to 30 minutes post baseline.

Conditions

Pain

Keywords

Acute; Pain; Emergency Department; Hydromorphone; Protocol

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Declined Additional Medication at 30 Minutes

  Amount of patients who choose to forgo additional pain medication at 30 minutes post-baseline when asked the question, "Do you want more pain medication?"

  30 minutes

• Mean Change in Pain Intensity Score From Baseline to 30 Minutes

  Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable"). The change in NRS score is calculated by subtracting the score at 30 minutes post treatment from the score at baseline, before treatment. The average of these values was calculated.

  30 minutes

Study Arms (2)

Hydromorphone

EXPERIMENTAL

2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.

Drug: Hydromorphone

Usual care

ACTIVE COMPARATOR

The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing

Drug: Usual care

Interventions

Hydromorphone DRUG

2 mg IV hydromorphone over to 2-3 minutes

Also known as: Dilaudid

Hydromorphone

Usual care DRUG

Attending administers IV opioid of his choosing

Also known as: Opioids

Usual care

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients.
• Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
• ED attending physician's judgment that patient's pain warrants IV opioids: The factors that influence the decision to use parenteral opioids are complex. An approach that is commonly taken to address the issue of patient selection in drug trials is to use a specific condition (e.g., renal colic) that would generally be thought to be appropriately treated with an opioid analgesic, thereby eliminating individual judgment about eligibility for the study. However in order to maximize the external validity of the role of opioids in the ED setting, the investigators decided to enroll patients with a variety of diagnoses, all with a complaint of acute pain. Opioids are not an appropriate treatment for all patients who present with a complaint of pain (e.g., gastroenteritis, migraine). Therefore, unless there is a restriction to patients with a specific diagnosis, either an extensive list of diagnoses and situations in which opioids are indicated must be specified, or clinical judgment needs to be used. The investigators have opted for the latter, since it most closely approximates the circumstances of clinical practice.

You may not qualify if:

• Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
• Prior adverse reaction to opioids.
• Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
• Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
• Systolic Blood Pressure \<90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
• Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
• Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
• C02 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows:
• All patients who have a history of chronic obstructive pulmonary disease (COPD)
• All patients who report a history of asthma together with greater than a 20 pack-year smoking history
• All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Emergency Department

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Chang AK, Bijur PE, Lupow JB, John Gallagher E. Randomized clinical trial of efficacy and safety of a single 2-mg intravenous dose of hydromorphone versus usual care in the management of acute pain. Acad Emerg Med. 2013 Feb;20(2):185-92. doi: 10.1111/acem.12071.

  PMID: 23406078 DERIVED

MeSH Terms

Conditions

Pain; Emergencies

Interventions

Hydromorphone; Analgesics, Opioid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Andrew Chang, MD, MS
• Organization: Department of Emergency Medicine, Montefiore Medical Center

achang@montefiore.org

718-920-7464

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 7, 2011
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 18, 2018
• Results First Posted: April 20, 2018

Record last verified: 2018-04

Locations

US (1)