PainPhase 4NCT00682435
Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients
A Phase 4 study testing Hydromorphone in people with Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone followed by an additional 1mg. Eligible patients will be given 1 mg intravenous (IV) hydromorphone. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- 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
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2007
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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 of age: Patients age 65 and over will be excluded in 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 ED literature.
- ED attending physician's judgment that patient's pain warrants use of morphine: The factors that influence the decision to use parenteral opioids are complex and extensive. 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) or treatment (e.g., post-hysterectomy) 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 assess the role of hydromorphone with the widest generalizability in the ED setting, we 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 a comprehensive list of diagnoses and situations in which opioids are indicated must be specified, or clinical judgment needs to be used. We have opted for the latter alternative.
- The use of patients with a variety of diagnoses, and therefore heterogeneous painful stimuli, risks masking a treatment effect because of large inter-individual variability. There are several design and analytic factors (detailed below) that attenuate this risk: 1) a sufficiently large number of patients will be randomly assigned to each group so that the variety of painful stimuli will be equally distributed between treatment groups; 2) change in pain intensity and pain relief will be analyzed rather than absolute pain intensity or pain relief therefore reducing variability.
- 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
- Prior use of methadone: the effect of methadone use on the perception of acute pain is unknown and suspected to be altered. We feel that the needs of patients on methadone may exceed the dosage ceiling of 2mg that will be used for this study. Similar to sickle cell patients and chronic cancer patients, patients on methadone usually require significantly higher doses of opioids to control their pain. Thus, we feel that it would be unethical to restrict the dose that this subset of patients can receive.
- Use of other opioids or tramadol within past seven days: 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.
- 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.
- Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter perception, report, and treatment of pain.
- Systolic Blood Pressure <90 mm Hg: Hydromorphone can produce peripheral vasodilation that may result in orthostatic hypotension or syncope.
Show all 13Show fewer
- 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: MAOs 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 a similar study (04-12-360), 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
- Pregnancy: this will be determined by asking the female of reproductive age about her pregnancy status and/or through the results of urine or serum pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Safety and Speed of Onsent of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg in the Treatment of Adult ED Patients With Moderate to Severe Pain
We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone followed by an additional 1mg. Eligible patients will be given 1 mg intravenous (IV) hydromorphone. At 15 minutes, these patients will be asked the question, "Do you need more pain medication?" Those that answer "yes" will receive an additional 1mg IV hydromorphone. Those that answer "no" will not receive additional pain medications at that time period (15 minutes). Thus, we wish to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will result in less incidence of oxygen desaturation.
If our study shows that this regimen is safe, its efficacy can be assessed in future trials. Positive results of those trials may lead to the use of this regimen to improve pain management in the emergency department.
Read the detailed description
Prospective interventional study at an urban academic emergency department (ED). One milligram of IV hydromorphone was administered to adults 21 to 64 years of age who had acute severe pain. Fifteen minutes later, patients were asked whether they wanted more pain medication. If they answered yes, they received another 1 mg of IV hydromorphone and were again asked 15 minutes later whether they wanted more pain medication. The primary efficacy outcome was the proportion of patients who had adequate analgesia, defined as declining additional hydromorphone within 1 hour of entering the protocol. The primary safety outcome was incidence of oxygen desaturation less than 95%. Secondary outcomes included numeric rating scale pain scores and adverse events.
- Conditions
- Pain
- Being tested
- Hydromorphone
- Keywords
- Nonelderly patients with acute moderate to severe pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called Dilaudid
1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone | Experimental | 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Had Adequate Analgesia
Adequate analgesia is defined as declining additional hydromorphone within 1 hour of entering the protocol
Measured: 60 minutes after medication infused
Number of Patients With Oxygen Desaturation Less Than 95%
primary safety outcome, defined as number of participants who experienced oxygen saturation < 95%
Measured: 120 minutes after medication infused
Secondary outcomes (2)
Number of Patients With Reduction in Pain Intensity
Pain intensity is measured on the numerical rating scale (NRS), with a pain score from 0 (no pain) to 10 (worst pain imaginable). The reduction in pain intensity is defined here as a change in pain score by 2 or more units.
Measured: 60 minutes after medication infused
Change in Pain Intensity
Pain intensity is measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable) from baseline to 60 minutes after medication infused
Measured: 60 minutes after medication infused
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startAug 2007
- Primary completionNov 2007
- Study completionNov 2007
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 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Chang, MD, Montefiore Medical Center
- Investigators
- Andrew Chang, M.D., Principal investigator, Motefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682435
- Sponsor's protocol ID
- MMC0702028
- Status last verified
- Aug 2018
- First submitted
- 19 May 2008
- Last updated
- 13 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Speed of Onsent of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg in the Treatment of Adult ED Patients With Moderate to Severe Pain
- ClinicalTrials.gov ID
- NCT00682435
- Acronym / sponsor ID
- MMC0702028
- Conditions
- Pain
- Keywords
- Nonelderly patients with acute moderate to severe pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Posted 13 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone followed by an additional 1mg. Eligible patients will be given 1 mg intravenous (IV) hydromorphone. At 15 minutes, these patients will be asked the question, "Do you need more pain medication?" Those that answer "yes" will receive an additional 1mg IV hydromorphone. Those that answer "no" will not receive additional pain medications at that time period (15 minutes). Thus, we wish to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will result in less incidence of oxygen desaturation.
If our study shows that this regimen is safe, its efficacy can be assessed in future trials. Positive results of those trials may lead to the use of this regimen to improve pain management in the emergency department.
Detailed description
Prospective interventional study at an urban academic emergency department (ED). One milligram of IV hydromorphone was administered to adults 21 to 64 years of age who had acute severe pain. Fifteen minutes later, patients were asked whether they wanted more pain medication. If they answered yes, they received another 1 mg of IV hydromorphone and were again asked 15 minutes later whether they wanted more pain medication. The primary efficacy outcome was the proportion of patients who had adequate analgesia, defined as declining additional hydromorphone within 1 hour of entering the protocol. The primary safety outcome was incidence of oxygen desaturation less than 95%. Secondary outcomes included numeric rating scale pain scores and adverse events.
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: Hydromorphone1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 of age: Patients age 65 and over will be excluded in 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 ED literature.
- ED attending physician's judgment that patient's pain warrants use of morphine: The factors that influence the decision to use parenteral opioids are complex and extensive. 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) or treatment (e.g., post-hysterectomy) 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 assess the role of hydromorphone with the widest generalizability in the ED setting, we 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 a comprehensive list of diagnoses and situations in which opioids are indicated must be specified, or clinical judgment needs to be used. We have opted for the latter alternative.
- The use of patients with a variety of diagnoses, and therefore heterogeneous painful stimuli, risks masking a treatment effect because of large inter-individual variability. There are several design and analytic factors (detailed below) that attenuate this risk: 1) a sufficiently large number of patients will be randomly assigned to each group so that the variety of painful stimuli will be equally distributed between treatment groups; 2) change in pain intensity and pain relief will be analyzed rather than absolute pain intensity or pain relief therefore reducing variability.
Key exclusion criteria (13 listed)
- Prior use of methadone: the effect of methadone use on the perception of acute pain is unknown and suspected to be altered. We feel that the needs of patients on methadone may exceed the dosage ceiling of 2mg that will be used for this study. Similar to sickle cell patients and chronic cancer patients, patients on methadone usually require significantly higher doses of opioids to control their pain. Thus, we feel that it would be unethical to restrict the dose that this subset of patients can receive.
- Use of other opioids or tramadol within past seven days: 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.
- 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.
- Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter perception, report, and treatment of pain.
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: Dilaudid1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?" | Drug | Hydromorphone |
Primary outcome
Number of Patients Who Had Adequate Analgesia
Time frame: 60 minutes after medication infused
Adequate analgesia is defined as declining additional hydromorphone within 1 hour of entering the protocol
Number of Patients With Oxygen Desaturation Less Than 95%
Time frame: 120 minutes after medication infused
primary safety outcome, defined as number of participants who experienced oxygen saturation < 95%
2 secondary outcomes
Number of Patients With Reduction in Pain Intensity
Time frame: 60 minutes after medication infused
Change in Pain Intensity
Time frame: 60 minutes after medication infused
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- 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 Chang, M.D. principal investigator
Motefiore 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 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 6 inclusion and 13 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 13 Aug 2018. 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 13 Aug 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 Patients Who Had Adequate Analgesia (time frame: 60 minutes after medication infused). The study lists 2 primary outcomes in all. 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 13 Aug 2018.