PainNCT00293969
A Trial Comparing Different Dosing Regimens of Morphine in Patients With Moderate to Severe Pain
A study testing Morphine 0.1mg/kg versus morphine 0.15 mg/kg in people with Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to administer intravenous opiates, what is the difference in pain relief at 60 minutes in patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg? HYPOTHESIS: In adult… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Morphine 0.1mg/kg versus morphine 0.15 mg/kg
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jan 2006
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 21 to 65 years of age presenting to the ED with pain of less than or equal to 7 days duration and deemed by the ED attending to require opioid analgesia are eligible for inclusion.
Who cannot join
- Inability or unwillingness to provide informed consent, methadone use, use of other opioids or tramadol within 7 days, prior adverse reaction to morphine, chronic pain syndrome, alcohol intoxication, pregnancy or breast-feeding, systolic blood pressure <90 mm Hg, use of MAO inhibitors, and weight greater than 100 kg.
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
Official title: A Randomized Clinical Trial Comparing Different Dosing Regimens of Intravenous Morphine in the Treatment of Adult Patients Presenting to the Emergency Department With Moderate to Severe Pain
RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to administer intravenous opiates, what is the difference in pain relief at 60 minutes in patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg?
HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.
SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may be able to provide evidence to suggest that the higher dose should be used for adult ED patients under the age of 66 presenting with acute pain.
Read the detailed description
RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to administer intravenous opiates, what is the between-group difference in before-after improvement in pain relief at 60 minutes in patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg?
HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.
SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may be able to provide evidence to suggest that the higher dose should be used for adult ED patients under the age of 66 presenting with acute pain.
METHODS/DESIGN: Prospective, double blind, randomized clinical trial. Adult ED patients between the ages of 18 and 65 years of age in whom the attending ED physician has decided to administer parenteral opiates, will be randomized to receive either 0.1 mg/kg IV morphine (maximum dose of 10 mg) or 0.15mg/kg IV morphine (maximum dose of 15 mg). An on-line random plan generator (http://www.randomization.com) will be used to generate an allocation schedule. The allocation schedule will be fully documented with the reference citation of the pseudo-random number generator, the seed used to start the generation process, the number of treatments (2), the allocation ratio (1:1), the size and number of blocks, and a copy of the assignment list. The allocation schedule will be given to the Montefiore Department of Pharmacy where it will be used to determine the content of consecutively numbered vials with either the study doses of morphine. The Pharmacy Department will prepare and handle the vials in accordance with known stability data and labeled with expiration dates. They will provide the study with labeled packages containing the numbered vial, a label with the vial number to be attached to the patient's data collection instrument, an opaque envelope with the assignment group identified (to be used in the event of a clinical emergency that requires immediate determination of what the patient received) and a weight based dosing schedule for morphine. All patients will receive a bolus of morphine 0.1mg/kg at time 0. At 30 minutes, patients will receive the study drug which will contain either an additional 0.05mg/kg of morphine or placebo. After the initial morphine bolus and study drug, patients will have received either morphine 0.1 mg/kg (maximum of 10 mg) or 0.15 mg/kg (maximum of 15mg).
- Conditions
- Pain
- Being tested
- Morphine 0.1mg/kg versus morphine 0.15 mg/kg
- Keywords
- Pain, Morphine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine 0.1mg/kg versus morphine 0.15 mg/kgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The between-group difference in mean before-after difference in pain score at baseline and 60 minutes in patients randomized to receive either 0.10 mg/kg or 0.15 mg/kg morphine
Secondary outcomes (6)
Between-group comparison of mean change in pain score from 30 min to 60 min
Comparison of between-group differences in pain relief scores
Patient satisfaction score
Adverse events at 30 and 60 minutes
Number of additional boluses of analgesics needed within 60 minutes for the two groups.
NRS pain score percent reduction at 60 min calculated as NRS pain score reduction from baseline to 60 min divided by baseline NRS score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2005
- Study completionJan 2006
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Adrienne J. Birnbaum, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293969
- Sponsor's protocol ID
- 04-12-360
- Status last verified
- Jan 2006
- First submitted
- 17 Feb 2006
- Last updated
- 20 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Different Dosing Regimens of Intravenous Morphine in the Treatment of Adult Patients Presenting to the Emergency Department With Moderate to Severe Pain
- ClinicalTrials.gov ID
- NCT00293969
- Acronym / sponsor ID
- 04-12-360
- Conditions
- Pain
- Keywords
- Pain, Morphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Jan 2006
- First posted
- 20 Feb 2006 (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.
RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to administer intravenous opiates, what is the difference in pain relief at 60 minutes in patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg?
HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.
SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may be able to provide evidence to suggest that the higher dose should be used for adult ED patients under the age of 66 presenting with acute pain.
Detailed description
RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to administer intravenous opiates, what is the between-group difference in before-after improvement in pain relief at 60 minutes in patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg?
HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.
SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may be able to provide evidence to suggest that the higher dose should be used for adult ED patients under the age of 66 presenting with acute pain.
METHODS/DESIGN: Prospective, double blind, randomized clinical trial. Adult ED patients between the ages of 18 and 65 years of age in whom the attending ED physician has decided to administer parenteral opiates, will be randomized to receive either 0.1 mg/kg IV morphine (maximum dose of 10 mg) or 0.15mg/kg IV morphine (maximum dose of 15 mg). An on-line random plan generator (http://www.randomization.com) will be used to generate an allocation schedule. The allocation schedule will be fully documented with the reference citation of the pseudo-random number generator, the seed used to start the generation process, the number of treatments (2), the allocation ratio (1:1), the size and number of blocks, and a copy of the assignment list. The allocation schedule will be given to the Montefiore Department of Pharmacy where it will be used to determine the content of consecutively numbered vials with either the study doses of morphine. The Pharmacy Department will prepare and handle the vials in accordance with known stability data and labeled with expiration dates. They will provide the study with labeled packages containing the numbered vial, a label with the vial number to be attached to the patient's data collection instrument, an opaque envelope with the assignment group identified (to be used in the event of a clinical emergency that requires immediate determination of what the patient received) and a weight based dosing schedule for morphine. All patients will receive a bolus of morphine 0.1mg/kg at time 0. At 30 minutes, patients will receive the study drug which will contain either an additional 0.05mg/kg of morphine or placebo. After the initial morphine bolus and study drug, patients will have received either morphine 0.1 mg/kg (maximum of 10 mg) or 0.15 mg/kg (maximum of 15mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 21 to 65 years of age presenting to the ED with pain of less than or equal to 7 days duration and deemed by the ED attending to require opioid analgesia are eligible for inclusion.
Key exclusion criteria (1 listed)
- Inability or unwillingness to provide informed consent, methadone use, use of other opioids or tramadol within 7 days, prior adverse reaction to morphine, chronic pain syndrome, alcohol intoxication, pregnancy or breast-feeding, systolic blood pressure <90 mm Hg, use of MAO inhibitors, and weight greater than 100 kg.
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 |
|---|---|---|
| Morphine 0.1mg/kg versus morphine 0.15 mg/kg | Drug | – |
Primary outcome
The between-group difference in mean before-after difference in pain score at baseline and 60 minutes in patients randomized to receive either 0.10 mg/kg or 0.15 mg/kg morphine
6 secondary outcomes
Between-group comparison of mean change in pain score from 30 min to 60 min
Comparison of between-group differences in pain relief scores
Patient satisfaction score
Adverse events at 30 and 60 minutes
Number of additional boluses of analgesics needed within 60 minutes for the two groups.
NRS pain score percent reduction at 60 min calculated as NRS pain score reduction from baseline to 60 min divided by baseline NRS score
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 20 Feb 2006.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Adrienne J. Birnbaum, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine 0.1mg/kg versus morphine 0.15 mg/kg 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 1 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 20 Feb 2006. 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.
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?
The between-group difference in mean before-after difference in pain score at baseline and 60 minutes in patients randomized to receive either 0.10 mg/kg or 0.15 mg/kg morphine. 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 20 Feb 2006.