Acute Severe PainPhase 4NCT01892709
Titration of Intravenous Hydromorphone
A Phase 4 study testing Hydromorphone in people with Acute Severe Pain, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Severe Pain
- What is being tested?
- Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Apr 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. 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.
- 2. 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.
- 3. 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.
- 4. ED attending physician's judgment that patient's pain warrants use of morphine
- 5. 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.
Who cannot join
- 1. 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.
- 2. 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.
- 3. Prior adverse reaction to hydromorphone: patients will be excluded if they state that they have an allergy to hydromorphone.
- 4. 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.
- 5. 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.
- 6. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter perception, report, and treatment of pain.
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- 7. Systolic Blood Pressure <100 mm Hg: Hydromorphone can produce peripheral vasodilation that may result in orthostatic hypotension or syncope.
- 8. Respiratory rate < 12/minute: Hydromorphone can cause respiratory depression.
- 9. Oxygen saturation <95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
- 10. Heart rate < 60 beats/minute: Hydromorphone can cause bradycardia.
- 11. 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.
- 12. 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center Moses Emegency Department
The Bronx, New York, 10467
About this study
Official title: Efficacy of an Acute Pain Titration Protocol Driven by Patient Response to a Simple Query: Do You Want More Pain Medication?
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
- Being tested
- Hydromorphone
- Keywords
- acute, pain, emergency department, hydromorphone, in ER
- Medical subject headings
- Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called Dilaudid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours
Secondary outcomes (1)
Adverse Events and Side Effects by Total Amount of Hydromorphone Received
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Severe PainStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew K Chang, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892709
- Sponsor's protocol ID
- 12-12-408
- Status last verified
- May 2023
- First submitted
- 6 Jun 2013
- Last updated
- 31 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Acute Pain Titration Protocol Driven by Patient Response to a Simple Query: Do You Want More Pain Medication?
- ClinicalTrials.gov ID
- NCT01892709
- Acronym / sponsor ID
- 12-12-408
- Conditions
- Acute Severe Pain
- Keywords
- acute, pain, emergency department, hydromorphone, in ER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Posted 24 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone | Experimental | Drug: HydromorphoneAll 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. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. 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.
- 2. 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.
- 3. 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.
- 4. ED attending physician's judgment that patient's pain warrants use of morphine
- 5. 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.
Key exclusion criteria (15 listed)
- 1. 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.
- 2. 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.
- 3. Prior adverse reaction to hydromorphone: patients will be excluded if they state that they have an allergy to hydromorphone.
- 4. 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.
- 5. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneAlso: Dilaudid | Drug | Hydromorphone |
Primary outcome
Number of Participants Requesting Pain Medication in Different Patterns Over Time
Time frame: 4 hours
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
1 secondary outcome
Adverse Events and Side Effects by Total Amount of Hydromorphone Received
Time frame: 120 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew K Chang, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone in people with Acute Severe Pain, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Requesting Pain Medication in Different Patterns Over Time (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.