PainPhase 4NCT01429298
Comparing Intravenous Hydromorphone to Usual Care
A Phase 4 study testing Hydromorphone in people with Pain, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 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
- Mar 2010to Nov 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
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: Randomized Clinical Trial Comparing Intravenous Hydromorphone to Usual Care
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.
Read the detailed description
Patients were randomized to the 2 mg IV hydromorphone group or usual care; allocation was generated with www.randomization.com, using sealed opaque envelopes opened in sequential order by the research assistants (RAs) immediately following enrollment. Patients randomly allocated to usual care received an initial dose of IV opioid; the type and dose of which was determined by the treating emergency physician (EP). Patients in the 2 mg hydromorphone group were allocated to receive 2 mg IV hydromorphone, administered slowly over 2 to 3 minutes. All patients were placed on 2 L O2 by nasal cannula. Subjects were blinded to the treatment they were assigned. At 30 minutes, both groups were asked the following scripted question: "Do you want more pain medication?" Patients in either group who answered or otherwise indicated "yes" had their treating attending physician notified, who then decided on further pain management. Those who answered or otherwise indicated "no" did not receive additional analgesic at that time. Attending physicians were thus able to treat patients' pain in any manner they deemed fit once this primary study endpoint was reached. In addition to acquisition of the primary endpoint, patients were also asked to rate their pain on a previously validated and reproducible standard verbal NRS ranging from 0 ("no pain") through 10 ("worst pain possible") at 15, 30, 45, 60, 90, and 120 minutes following administration of the initial opioid dose at time 0. For safety reasons, patients were monitored for a total of 120 minutes (i.e., 90 minutes past the primary study endpoint) to determine adverse effects. Systolic blood pressure, heart rate, oxygen saturation, nausea, vomiting, and pruritus were assessed at baseline and at 15, 30, 45, 60, 90, and 120 minutes after initial administration of opioid. Patients who experienced oxygen desaturation (defined as < 95%) were gently aroused if sleeping, asked to take several deep breaths, and repositioned into a sitting position if they had been in a reclined position. Nasal cannula oxygen was also increased to 4 L, and the treating attending physician was notified. Subsequent management, including the use of naloxone, was per the treating attending physician's discretion.
- Conditions
- Pain
- Being tested
- Hydromorphone, Usual care
- Keywords
- Acute, Pain, Emergency Department, Hydromorphone, Protocol
- 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
2 mg IV hydromorphone over to 2-3 minutes
Usual careDrug
Also called Opioids
Attending administers IV opioid of his choosing
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone | Experimental | 2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose. Receives: 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 Receives: Drug: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 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.
Measured: 30 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 startMar 2010
- Primary completionNov 2010
- Study completionNov 2010
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
- NCT01429298
- Sponsor's protocol ID
- MMC 09-11-346
- 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, 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.
PubMed 23406078
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
- Randomized Clinical Trial Comparing Intravenous Hydromorphone to Usual Care
- ClinicalTrials.gov ID
- NCT01429298
- Acronym / sponsor ID
- MMC 09-11-346
- Conditions
- Pain
- Keywords
- Acute, Pain, Emergency Department, Hydromorphone, Protocol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Posted 20 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients were randomized to the 2 mg IV hydromorphone group or usual care; allocation was generated with www.randomization.com, using sealed opaque envelopes opened in sequential order by the research assistants (RAs) immediately following enrollment. Patients randomly allocated to usual care received an initial dose of IV opioid; the type and dose of which was determined by the treating emergency physician (EP). Patients in the 2 mg hydromorphone group were allocated to receive 2 mg IV hydromorphone, administered slowly over 2 to 3 minutes. All patients were placed on 2 L O2 by nasal cannula. Subjects were blinded to the treatment they were assigned. At 30 minutes, both groups were asked the following scripted question: "Do you want more pain medication?" Patients in either group who answered or otherwise indicated "yes" had their treating attending physician notified, who then decided on further pain management. Those who answered or otherwise indicated "no" did not receive additional analgesic at that time. Attending physicians were thus able to treat patients' pain in any manner they deemed fit once this primary study endpoint was reached. In addition to acquisition of the primary endpoint, patients were also asked to rate their pain on a previously validated and reproducible standard verbal NRS ranging from 0 ("no pain") through 10 ("worst pain possible") at 15, 30, 45, 60, 90, and 120 minutes following administration of the initial opioid dose at time 0. For safety reasons, patients were monitored for a total of 120 minutes (i.e., 90 minutes past the primary study endpoint) to determine adverse effects. Systolic blood pressure, heart rate, oxygen saturation, nausea, vomiting, and pruritus were assessed at baseline and at 15, 30, 45, 60, 90, and 120 minutes after initial administration of opioid. Patients who experienced oxygen desaturation (defined as < 95%) were gently aroused if sleeping, asked to take several deep breaths, and repositioned into a sitting position if they had been in a reclined position. Nasal cannula oxygen was also increased to 4 L, and the treating attending physician was notified. Subsequent management, including the use of naloxone, was per the treating attending physician's discretion.
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: Hydromorphone2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose. |
| Usual care | Active comparator | Drug: Usual careThe attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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: Dilaudid2 mg IV hydromorphone over to 2-3 minutes | Drug | Hydromorphone |
| Usual careAlso: OpioidsAttending administers IV opioid of his choosing | Drug | Usual care |
Primary outcome
Number of Participants Who Declined Additional Medication at 30 Minutes
Time frame: 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?"
Mean Change in Pain Intensity Score From Baseline to 30 Minutes
Time frame: 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.
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 23406078Chang 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.
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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 3 inclusion and 11 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 20 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 Who Declined Additional Medication at 30 Minutes (time frame: 30 minutes). 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?
On the ClinicalTrials.gov record for NCT01429298, 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.