Titration of Intravenous Hydromorphone

NCT01892709 | Completed Phase 4 Results

• 1 other identifier: 12-12-408
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory, hypothesis-generating safety and efficacy study for patients who come to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic pain will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV hydromorphone over a 4 hour period. Hydromorphone will be given as 1 mg increments based on how the patient responds to the question, "Do you want more pain medicine?". This question will be asked repeatedly 30 minutes after the patient answers "no" or 30 minutes after the most recent dose of IV hydromorphone (which occurs if the patient answers "yes"). Up to 10% (approximately 30 patients) will serve as a pilot at the start of the study.

Conditions

Acute Severe Pain

Keywords

acute; pain; emergency department; hydromorphone; in ER

Outcome Measures

Primary Outcomes (1)

• Number of Participants Requesting Pain Medication in Different Patterns Over Time

  This is a descriptive hypothesis-generating trial, which is why it is not being compared in a randomized fashion to a comparison group. We are examining extended titration by expanding our "1+1" protocol to a "1+1+1+1" protocol and the various patterns of opioid request. For example, some may state "no" every time they are asked "Do you want more pain medication?" Some will state "yes" each time, and others will answer "yes" and "no" at different time periods. We will report these various patterns (i.e. X participants answered "no" everytime they were asked, Y answered "yes" everytime they were asked, Z answered "no" twice, etc). Time points 2, 3, and 4 are dependent on patient response to "Do you want more pain medication?" Time 1 is 30 min post-baseline. For those who answer "no", Time 2 is 30 minutes later (at 1 hour), and for yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours

  4 hours

Secondary Outcomes (1)

• Adverse Events and Side Effects by Total Amount of Hydromorphone Received

  120 min

Study Arms (1)

Hydromorphone

EXPERIMENTAL

All eligible patients will receive 1 mg IV hydromorphone. Thereafter, they will be repeatedly asked the question, "Do you want more pain medicine?" This question will be asked 30 minutes after they answered "no" or 30 minutes after the completion of the next dose of 1 mg IV hydromorphone, which occurs when the patients answers "yes". Patients will receive a maximum of 4 mg IV hydromorphone over a 4 hour period.

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

Also known as: Dilaudid

Hydromorphone

Eligibility Criteria

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

You may qualify if:

• \. Age greater than 21 years: Patients under the age of 21 are automatically triaged to the Children's Hospital at Montefiore Emergency Department, and hence cannot be enrolled in this study.
• \. Age less than 65 years: Patients age 65 and over will be excluded from this study as the effects on opioids on the elderly may be different than in the non-elderly.
• \. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in Emergency Department (ED) literature.
• \. ED attending physician's judgment that patient's pain warrants use of morphine
• \. Normal mental status: In order to provide measures of pain experienced the patient needs to have a normal mental status. Orientation to person, place and time will be used as an indicator of sufficiently normal mental status to participate in the study.

You may not qualify if:

• \. Prior use of methadone: the effect of methadone use on the perception of acute pain is unknown and suspected to be altered. Similar to sickle cell patients and chronic cancer patients, patients on methadone usually require significantly higher doses of opioids to control their pain.
• \. Use of other opioids or tramadol within past 24 hours: to avoid introducing bias related to opioid tolerance that may alter the response to the study medication thereby masking the medication's effect.
• \. Prior adverse reaction to hydromorphone: patients will be excluded if they state that they have an allergy to hydromorphone.
• \. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months result in alteration in 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, migraine, and peripheral neuropathies.
• \. Patients for whom the attending physician suspects is addicted to opioids: patients will be excluded if the attending suspects the patient may be addicted to opioids or seeking to obtain them for diversionary reasons, such as for monetary profit or other illicit use.
• \. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter perception, report, and treatment of pain.
• \. Systolic Blood Pressure \<100 mm Hg: Hydromorphone can produce peripheral vasodilation that may result in orthostatic hypotension or syncope.
• \. Respiratory rate \< 12/minute: Hydromorphone can cause respiratory depression.
• \. Oxygen saturation \<95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
• \. Heart rate \< 60 beats/minute: Hydromorphone can cause bradycardia.
• \. Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAOs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
• \. Carbon dioxide measurement greater than 46: three subsets of patients will have their carbon dioxide measured using a handheld capnometer prior to enrollment in the study. If the carbon dioxide 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 Medical Center Moses Emegency Department

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Pain; Emergencies

Interventions

Hydromorphone

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

Results Point of Contact

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

achang@montefiore.org

718-920-7476

Study Officials

• Andrew K Chang, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: July 4, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 31, 2023
• Results First Posted: April 24, 2018

Record last verified: 2023-05

Locations

US (1)