Acute PainPhase 3NCT00627367
Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain
A Phase 3 study testing Hydromorphone and Nonprotocolized in people with Acute Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and no more adverse events than patients receiving non-protocolized pain management. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Hydromorphone and Nonprotocolized
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2008
- 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: 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 64 was selected as an upper range for inclusion because substantial evidence supports age as being an important determinant of morphine requirement over longer periods of time.
- Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
- Emergency Department (ED) attending physician's judgment that patient's pain warrants use of intravenous opioids: The factors that influence the decision to use intravenous 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 intravenous (IV) opioids 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 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.
- 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.
- Use of other opioids, tramadol, or heroin in the past seven days: to avoid introducing bias related to opioid tolerance that may alter the response to intravenous opioids thereby masking the effects of the medications administered.
- Prior adverse reaction to morphine, hydromorphone, or other opioids: An exception will be if the patient has received opioid medications in the past without adverse event (i.e. a patient may state he is allergic to morphine but has received hydromorphone in the past without any adverse effects)
- Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months resulting 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 may alter the perception, report, and treatment of pain. Alcohol intoxication will be determined to exist as judged by the treating physician.
- Systolic Blood Pressure < 90 mm Hg: Opioids produce peripheral vasodilation that may result in orthostatic hypotension or syncope.
Show all 14Show 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 depression of respiration or coma.
- Weight less than 100 pounds: we are concerned that hydromorphone in doses up to 2 mg may not be safe in patients weighing less than 100 lbs.
- Baseline room air oxygen saturation less than 95%: since IV opioids may cause respiratory depression and result in hypoxemia, we are excluding this subgroup of patients.
- C02 measurement greater than 46: In accordance with a similar study (04-12-360), 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
The Bronx, New York, 10467
About this study
Official title: A Randomized Controlled Trial Comparing Protocolized Versus Non-protocolized Treatment of Adult ED Patients With Acute Severe Pain
Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and no more adverse events than patients receiving non-protocolized pain management.
- Conditions
- Acute Pain
- Being tested
- Hydromorphone, Nonprotocolized
- Keywords
- Acute Pain, Emergency Department, ED, Hydromorphone, Dilaudid Protocolized Nonprotocolized Usual Care
- Medical subject headings
- Acute 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
Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
NonprotocolizedDrug
Also called Usual Care
An IV opioid the type and dose of which will be determined by the treating clinician
| Study group | Role | What they receive |
|---|---|---|
| Protocolized | Experimental | 1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?" Receives: Drug: Hydromorphone |
| Nonprotocolized | Active comparator | An IV opioid the type and dose of which will be determined by the treating clincian Receives: Drug: Nonprotocolized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline.
Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department).
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 posted3 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2008
- Study completionMar 2008
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 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
- 224 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, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627367
- Sponsor's protocol ID
- MMC 0710359
- Status last verified
- Apr 2018
- First submitted
- 21 Feb 2008
- Last updated
- 5 Apr 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 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Protocolized Versus Non-protocolized Treatment of Adult ED Patients With Acute Severe Pain
- ClinicalTrials.gov ID
- NCT00627367
- Acronym / sponsor ID
- MMC 0710359
- Conditions
- Acute Pain
- Keywords
- Acute Pain, Emergency Department, ED, Hydromorphone, Dilaudid Protocolized Nonprotocolized Usual Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Dec 2007 (actual)
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Posted 5 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and no more adverse events than patients receiving non-protocolized pain management.
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: Hydromorphone1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?" |
| Nonprotocolized | Active comparator | Drug: NonprotocolizedAn IV opioid the type and dose of which will be determined by the treating clincian |
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: 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 64 was selected as an upper range for inclusion because substantial evidence supports age as being an important determinant of morphine requirement over longer periods of time.
- Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
- Emergency Department (ED) attending physician's judgment that patient's pain warrants use of intravenous opioids: The factors that influence the decision to use intravenous 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 intravenous (IV) opioids 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 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.
- 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 (14 listed)
- Prior use of methadone: the effect of methadone use on the perception of acute pain is unknown and suspected to be altered.
- Use of other opioids, tramadol, or heroin in the past seven days: to avoid introducing bias related to opioid tolerance that may alter the response to intravenous opioids thereby masking the effects of the medications administered.
- Prior adverse reaction to morphine, hydromorphone, or other opioids: An exception will be if the patient has received opioid medications in the past without adverse event (i.e. a patient may state he is allergic to morphine but has received hydromorphone in the past without any adverse effects)
- Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months resulting 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 may alter the perception, report, and treatment of pain. Alcohol intoxication will be determined to exist as judged by the treating physician.
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: DilaudidHydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes | Drug | Protocolized |
| NonprotocolizedAlso: Usual CareAn IV opioid the type and dose of which will be determined by the treating clinician | Drug | Nonprotocolized |
Primary outcome
Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline.
Time frame: 60 minutes
Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 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
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 Nonprotocolized in people with Acute 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 5 Apr 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 5 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?
Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline. (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 5 Apr 2018.