Acute PainNCT01900847
Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department
A study testing Ketamine and Morphine in people with Acute Pain, run by University of Arizona at 1 site in United States.
Trial summary
Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Ketamine and Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2013to 1 Apr 2014
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting to Emergency Department in acute pain
- age 18 and over
- determined to require morphine for pain control by treating physician
Who cannot join
- Patients presenting with headache or head injury
- Patient with eye injury or eye pain
- Nontraumatic chest Pain
- Pregnant patients or women of childbearing potential
- Patients allergic to morphine or ketamine
- Patients with known history of narcotic/alcohol abuse or presenting for narcotic medication refill
Show all 9Show fewer
- Patients with hypertension: diastolic blood pressure > 100 OR systolic blood pressure > 180
- Patient whose pain is so severe that they are unable to give informed consent
- Patients who have had bad experiences to prior hallucinations from any origin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Health Network University Campus 1501 North Campbell Ave
Tucson, Arizona, 85724
About this study
Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department.
Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.
- Conditions
- Acute Pain
- Keywords
- Ketamine, Acute Pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
0.3mg/kg ketamine
MorphineDrug
Dosage of morphine determined by treating physician
placeboDrug
saline of same volume as appropriate weight based dose of ketamine
| Study group | Role | What they receive |
|---|---|---|
| Morphine and placebo | Active comparator | Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy Receives: Drug: Morphine; Drug: placebo |
| Morphine and Ketamine | Experimental | Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Receives: Drug: Ketamine; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Score
Pain 0-10 with 0 being no pain and 10 being the worst pain
Measured: Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug
Secondary outcomes (2)
Total Amount of Morphine and Other Pain Medications Administered
Measured: Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
Number of Participants With Adverse Events
Measured: Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study start1 Jun 2013
- Primary completion1 Apr 2014
- Study completion1 Apr 2014
Why it stopped: concern of side effects
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 Acute PainStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Emergency Physicians
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900847
- Sponsor's protocol ID
- 13-0045
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2013
- Last updated
- 17 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Berkman, M. R., Larsen, J., Smith, J., Caldwell, J., Waterbrook, A., Stolz, U., & Denninghoff, K. (2014). 369 Ketamine and Morphine versus Morphine Alone for Treatment of Acute Pain in the Emergency Department. Annals of Emergency Medicine, 64(4), S131-S132.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT01900847
- Acronym / sponsor ID
- 13-0045
- Conditions
- Acute Pain
- Keywords
- Ketamine, Acute Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: concern of side effects
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- American College of Emergency Physicians
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department.
Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine and placebo | Active comparator | Drug: Morphine, Drug: placeboPatient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy |
| Morphine and Ketamine | Experimental | Drug: Ketamine, Drug: MorphinePatient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting to Emergency Department in acute pain
- age 18 and over
- determined to require morphine for pain control by treating physician
Key exclusion criteria (9 listed)
- Patients presenting with headache or head injury
- Patient with eye injury or eye pain
- Nontraumatic chest Pain
- Pregnant patients or women of childbearing potential
- Patients allergic to morphine or ketamine
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 |
|---|---|---|
| Ketamine0.3mg/kg ketamine | Drug | Morphine and Ketamine |
| MorphineDosage of morphine determined by treating physician | Drug | Morphine and Ketamine, Morphine and placebo |
| placebosaline of same volume as appropriate weight based dose of ketamine | Drug | Morphine and placebo |
Primary outcome
Numeric Pain Score
Time frame: Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug
Pain 0-10 with 0 being no pain and 10 being the worst pain
2 secondary outcomes
Total Amount of Morphine and Other Pain Medications Administered
Time frame: Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
Number of Participants With Adverse Events
Time frame: Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBerkman, M. R., Larsen, J., Smith, J., Caldwell, J., Waterbrook, A., Stolz, U., & Denninghoff, K. (2014). 369 Ketamine and Morphine versus Morphine Alone for Treatment of Acute Pain in the Emergency Department. Annals of Emergency Medicine, 64(4), S131-S132.
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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 study testing Ketamine and Morphine in people with Acute Pain, run by University of Arizona 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 9 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: stopped early, as of the sponsor's last update on 17 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2023). 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?
Numeric Pain Score (time frame: Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug). 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 NCT01900847, 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 17 Jul 2023.