PainPhase 4NCT01429285
Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain
A Phase 4 study testing Hydromorphone in people with Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The hydromorphone protocol is more effective than usual care in Emergency Department (ED) patients age 65 years and older in terms of proportion who choose to forgo additional pain medication within 60 minutes post-baseline in the two groups. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- 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
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2012
- 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 65 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age greater than or equal to 65 years: This is a study of elderly patients.
- 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 may warrant intravenous (IV) opioids: 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 opioids with the widest generalizability 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 a comprehensive 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 alternative.
- Normal mental status: In order to provide measures of pain experienced the patient needs to have a normal mental status. The investigators will use a 6-item screener (Wilber 2008) 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. The investigators feel that the needs of patients on methadone may exceed the dosage ceiling of 1 mg 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, the investigators 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 opioids.
- Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results 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: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
Show all 12Show 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: 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 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Emergency Department
The Bronx, New York, 10467
About this study
Official title: Safety and Efficacy of Intravenous Hydromorphone Using Incremental Doses of 0.5 mg in Elderly ED Patients With Acute Severe Pain
The hydromorphone protocol is more effective than usual care in Emergency Department (ED) patients age 65 years and older in terms of proportion who choose to forgo additional pain medication within 60 minutes post-baseline in the two groups.
- Conditions
- Pain
- Being tested
- Hydromorphone, Usual care
- Keywords
- Pain, Hydromorphone, Acute, Emergency Department
- 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
0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
Usual careDrug
Attending administers any IV opioid in any dose he chooses
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone | Experimental | Hydromorphone protocol Receives: Drug: Hydromorphone |
| Usual care | Active comparator | Usual care Receives: Drug: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Successful Treatment
Number of patients with "successful treatment" is defined as the number of patients who declined additional pain medication within 1 hour of study entry when asked the question, "Do you want more pain medication?". This measure looks at declining pain medication at either 15 minutes or 60 minutes, whereas 4. Post-Hoc refers only to the answer to the question at the 60 minute mark post-baseline.
Measured: 1 hour
Secondary outcomes (1)
Mean Change in Pain Intensity From Baseline to 60 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 scores over time is calculated by subtracting the score at 60 minutes from the score at baseline (before treatment). These change values were then averaged.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJun 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429285
- Sponsor's protocol ID
- MMC 08-11-387
- Status last verified
- Apr 2018
- First submitted
- 2 Sep 2011
- Last updated
- 18 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chang AK, Bijur PE, Davitt M, Gallagher EJ. Randomized clinical trial of an intravenous hydromorphone titration protocol versus usual care for management of acute pain in older emergency department patients. Drugs Aging. 2013 Sep;30(9):747-54. doi: 10.1007/s40266-013-0103-y.
PubMed 23846749
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravenous Hydromorphone Using Incremental Doses of 0.5 mg in Elderly ED Patients With Acute Severe Pain
- ClinicalTrials.gov ID
- NCT01429285
- Acronym / sponsor ID
- MMC 08-11-387
- Conditions
- Pain
- Keywords
- Pain, Hydromorphone, Acute, Emergency Department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Posted 19 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hydromorphone protocol is more effective than usual care in Emergency Department (ED) patients age 65 years and older in terms of proportion who choose to forgo additional pain medication within 60 minutes post-baseline in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone | Experimental | Drug: HydromorphoneHydromorphone protocol |
| Usual care | Active comparator | Drug: Usual careUsual care |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 65 years: This is a study of elderly patients.
- 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 may warrant intravenous (IV) opioids: 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 opioids with the widest generalizability 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 a comprehensive 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 alternative.
- Normal mental status: In order to provide measures of pain experienced the patient needs to have a normal mental status. The investigators will use a 6-item screener (Wilber 2008) as an indicator of sufficiently normal mental status to participate in the study.
Key exclusion criteria (12 listed)
- Prior use of methadone: the effect of methadone use on the perception of acute pain is unknown and suspected to be altered. The investigators feel that the needs of patients on methadone may exceed the dosage ceiling of 1 mg 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, the investigators 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 opioids.
- Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results 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: Dilaudid0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose | Drug | Hydromorphone |
| Usual careAttending administers any IV opioid in any dose he chooses | Drug | Usual care |
Primary outcome
Number of Patients With Successful Treatment
Time frame: 1 hour
Number of patients with "successful treatment" is defined as the number of patients who declined additional pain medication within 1 hour of study entry when asked the question, "Do you want more pain medication?". This measure looks at declining pain medication at either 15 minutes or 60 minutes, whereas 4. Post-Hoc refers only to the answer to the question at the 60 minute mark post-baseline.
1 secondary outcome
Mean Change in Pain Intensity From Baseline to 60 Minutes
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23846749Chang AK, Bijur PE, Davitt M, Gallagher EJ. Randomized clinical trial of an intravenous hydromorphone titration protocol versus usual care for management of acute pain in older emergency department patients. Drugs Aging. 2013 Sep;30(9):747-54. doi: 10.1007/s40266-013-0103-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 inclusion and 12 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 18 May 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 19 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 Patients With Successful Treatment (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01429285, which also lists 1 linked publication.
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 18 May 2018.