PainPhase 3NCT00825370
Protocolized vs Discretionary Use of Opioids in Acute Pain
A Phase 3 study testing Hydromorphone and IV opioid in people with Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the… Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Hydromorphone and IV opioid
- 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
- Oct 2008to May 2009
- Phase
- Phase 3
- 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
- Age 21 to 64 years.
- Pain with onset within 7 days.
- Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids.
- Normal mental status.
Who cannot join
- Prior use of methadone.
- Use of other opioids, tramadol, or heroin in the past seven days.
- Prior adverse reaction to morphine, hydromorphone, or other opioids.
- Chronic pain syndrome.
- Alcohol intoxication.
- Systolic Blood Pressure < 90 mm Hg.
Show all 14Show fewer
- Use of monoamine oxidase (MAO) inhibitors in past 30 days.
- Weight less than 100 pounds.
- Baseline room air oxygen saturation less than 95%.
- C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, four 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 4 subsets are as follows:
- All patients who have a history of chronic obstructive pulmonary disease (COPD)
- All patients who have a history of sleep apnea
- 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 Emergency Department
The Bronx, New York, 10467
About this study
We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.
- Conditions
- Pain
- Being tested
- Hydromorphone, IV opioid
- Keywords
- Hydromorphone, acute pain, Protocolized, Efficacy, Safety
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called Dilaudid
1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
IV opioidDrug
Also called Discretionary care
Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
| Study group | Role | What they receive |
|---|---|---|
| Protocolized | Experimental | 1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, "Do you want more pain medication?" Receives: Drug: Hydromorphone |
| Discretionary Care | Active comparator | Patients receive an IV opioid the type and dose of which is determined by the treating physician Receives: Drug: IV opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Successful Treatment
Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes
Measured: 60 minutes
Secondary outcomes (3)
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes
As defined by the percentage of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes
Measured: 15 min
Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes
Patients who did not want pain medication determined by those who answered "no" to the question "do you want more pain medication?" at 60 minutes after treatment.
Measured: 60 minutes
Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The averages were calculated by finding the mean of change in pain intensity for each patient.
Measured: Up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- Investigators
- Andrew K Chang, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825370
- Sponsor's protocol ID
- MMC 0808278
- Status last verified
- May 2018
- First submitted
- 19 Jan 2009
- Last updated
- 12 Jun 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocolized vs Discretionary Use of Opioids in Acute Pain
- ClinicalTrials.gov ID
- NCT00825370
- Acronym / sponsor ID
- MMC 0808278
- Conditions
- Pain
- Keywords
- Hydromorphone, acute pain, Protocolized, Efficacy, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Oct 2008 (actual)
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Jan 2009 (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.
We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocolized | Experimental | Drug: Hydromorphone1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, "Do you want more pain medication?" |
| Discretionary Care | Active comparator | Drug: IV opioidPatients receive an IV opioid the type and dose of which is determined by the treating physician |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 21 to 64 years.
- Pain with onset within 7 days.
- Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids.
- Normal mental status.
Key exclusion criteria (14 listed)
- Prior use of methadone.
- Use of other opioids, tramadol, or heroin in the past seven days.
- Prior adverse reaction to morphine, hydromorphone, or other opioids.
- Chronic pain syndrome.
- Alcohol intoxication.
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: Dilaudid1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later | Drug | Protocolized |
| IV opioidAlso: Discretionary careAny IV opioid in the dose chosen by the treating physician. May include hydromorphone as well. | Drug | Discretionary Care |
Primary outcome
Percentage of Patients With Successful Treatment
Time frame: 60 minutes
Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes
3 secondary outcomes
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes
Time frame: 15 min
Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes
Time frame: 60 minutes
Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
Time frame: Up to 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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 K Chang, MD 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 3 study testing Hydromorphone and IV opioid 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 14 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 12 Jun 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of Patients With Successful Treatment (time frame: 60 minutes). 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 12 Jun 2018.