PainPhase 2NCT00195910
Safety and Efficacy Study of Hydromorphone and Morphine
A Phase 2 study testing Morphine and Hydromorphone in people with Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain. 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?
- Morphine and Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jan 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- adults between the ages of 21 and 65 who presented to the ED with acute pain (defined as pain less than 7 days in duration) (23) of sufficient severity in the judgment of the ED attending to warrant use of IV opioids.
Who cannot join
- previous allergy to morphine or hydromorphone
- systolic blood pressure less than 90 mmHg
- alcohol intoxication as judged by the attending physician
- use of other opioids within the past 7 days
- use of an Monoamine Oxidase (MAO) inhibitor
- chronic pain syndromes (such as sickle cell disease or fibromyalgia)
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 Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial
To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.
Read the detailed description
There is widespread agreement that pain is under-treated in the Emergency Department (ED). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved. Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients' acute pain. In spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
0.1 mg/kg IV morphine
HydromorphoneDrug
Also called Dilaudid
0.015 mg/kg IV hydromorphone
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | single dose of intravenous (IV) morphine, 0.1 mg/kg
intervention: 0.1 mg/kg IV morphine Receives: Drug: Morphine |
| Hydromorphone | Experimental | single dose of intravenous (IV) hydromorphone, 0.015 mg/kg
intervention: 0.015 mg/kg IV hydromorphone Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity from baseline to 30 minutes after medications were infused.
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable)
Measured: baseline to 30 minutes after medication infused
Secondary outcomes (9)
Pain intensity 5 minutes after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 5 minutes after medication is given
Pain intensity 30 minutes after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 30 minutes after medication is given
Pain intensity 2 hours after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 2 hours after medication is given
Number of participants experiencing vomiting between baseline to 5 minutes after medication is given
Number of participants who experienced vomiting and required medication between baseline and 5 minutes after medication was infused
Measured: baseline to 5 minutes after medication is given
Number of participants experiencing vomiting between 6 minutes after medication is given to 30 minutes after medication is given
Number of participants who experienced vomiting and required medication between 6 minutes after medication was infused and 30 minutes after medication was infused
Measured: 6 minutes after medication is given to 30 minutes after medication is given
Number of participants experiencing vomiting between 31 minutes after medication is given to 120 minutes after medication is given
Number of participants who experienced vomiting and required medication between 31 minutes after medication was infused and 120 minutes after medication was infused
Measured: 31 minutes after medication is given to 120 minutes after medication is given
Number of participants who received additional pain medication between baseline and 5 minutes after medication was infused
Number of participants for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between baseline and 5 minutes after medication was infused
Measured: baseline to 5 minutes after medication was infused
Number of participants who received additional pain medication between 6 and 30 minutes after medication was infused
Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 6 and 30 minutes after the medication was infused
Measured: 6 minutes to 30 minutes after medication was infused
Number of participants who received additional pain medication between 31 and 120 minutes after medication was infused
Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 31 and 120 minutes after medication was infused
Measured: 31 minutes to 120 minutes after medication was infused
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 198 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
- NCT00195910
- Sponsor's protocol ID
- MMC-04-08-225
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2005
- Last updated
- 15 Aug 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00195910
- Acronym / sponsor ID
- MMC-04-08-225
- Conditions
- Pain
- Keywords
- Acute, Pain, Emergency Department, Morphine, Hydromorphone, Dilaudid, oligoanalgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Oct 2004 (actual)
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.
Detailed description
There is widespread agreement that pain is under-treated in the Emergency Department (ED). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved. Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients' acute pain. In spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: Morphinesingle dose of intravenous (IV) morphine, 0.1 mg/kg intervention: 0.1 mg/kg IV morphine |
| Hydromorphone | Experimental | Drug: Hydromorphonesingle dose of intravenous (IV) hydromorphone, 0.015 mg/kg intervention: 0.015 mg/kg IV hydromorphone |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults between the ages of 21 and 65 who presented to the ED with acute pain (defined as pain less than 7 days in duration) (23) of sufficient severity in the judgment of the ED attending to warrant use of IV opioids.
Key exclusion criteria (6 listed)
- previous allergy to morphine or hydromorphone
- systolic blood pressure less than 90 mmHg
- alcohol intoxication as judged by the attending physician
- use of other opioids within the past 7 days
- use of an Monoamine Oxidase (MAO) inhibitor
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 |
|---|---|---|
| Morphine0.1 mg/kg IV morphine | Drug | Morphine |
| HydromorphoneAlso: Dilaudid0.015 mg/kg IV hydromorphone | Drug | Hydromorphone |
Primary outcome
Change in Pain Intensity from baseline to 30 minutes after medications were infused.
Time frame: baseline to 30 minutes after medication infused
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable)
9 secondary outcomes
Pain intensity 5 minutes after medication is given
Time frame: 5 minutes after medication is given
Pain intensity 30 minutes after medication is given
Time frame: 30 minutes after medication is given
Pain intensity 2 hours after medication is given
Time frame: 2 hours after medication is given
Number of participants experiencing vomiting between baseline to 5 minutes after medication is given
Time frame: baseline to 5 minutes after medication is given
Number of participants experiencing vomiting between 6 minutes after medication is given to 30 minutes after medication is given
Time frame: 6 minutes after medication is given to 30 minutes after medication is given
Number of participants experiencing vomiting between 31 minutes after medication is given to 120 minutes after medication is given
Time frame: 31 minutes after medication is given to 120 minutes after medication is given
Number of participants who received additional pain medication between baseline and 5 minutes after medication was infused
Time frame: baseline to 5 minutes after medication was infused
Number of participants who received additional pain medication between 6 and 30 minutes after medication was infused
Time frame: 6 minutes to 30 minutes after medication was infused
Number of participants who received additional pain medication between 31 and 120 minutes after medication was infused
Time frame: 31 minutes to 120 minutes after medication was infused
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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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 2 study testing Morphine and 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 1 inclusion and 6 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 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pain Intensity from baseline to 30 minutes after medications were infused. (time frame: baseline to 30 minutes after medication infused). 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 15 Aug 2018.