Acute PainPhase 4KetMoNCT05422001
Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED
A Phase 4 study testing low dose ketamine in people with Acute Pain and Opioid Use, run by University of Aarhus at 1 site in Denmark.
Trial summary
The KetMo study is an investigator-initiated, randomized, parallel group, double blinded trial investigating if ketamine as an adjunct to morphine improves pain treatment in the ED. Patients in pain (assessed on NRS, 5 or more) will be randomized to low-dose ketamine or placebo as an adjunct to morphine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Opioid Use
- What is being tested?
- low dose ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteDenmark
- Study dates
- 31 May 2022to 15 Aug 2023
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency Department admission
- Age ≥ 18 years
- NRS ≥ 5
- Stable vital signs defined as systolic blood pressure ≥ 90 mmHg, heart rate between 60 and 150 per minute, respiratory rate between 8 and 26 per minute, oxygen saturation greater than or equal to 92%
Who cannot join
- Initial management by trauma-team
- Systolic blood pressure ≥ 180mmHg, severe untreated arrhythmia, unstable angina, recent myocardial infarction (< 30 days), severe heart-failure (Ejection fraction < 40 %)
- Symptoms of untreated hyperthyroidism
- Cirrhosis with ascites
- Known/suspected pregnancy or breastfeeding
- Patients for whom consent is not obtainable or psychiatric forced treatment.
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- Previously enrolled in the trial
- Psychiatric illness prior to admission defined as prior psychosis/schizophrenia
- Untreated diagnosed glaucoma
- Known hypersensitivity to ketamine or to any excipient or prior use of ketamine with a negative experience (i.e. hallucinations)
- Patient clearly influenced by drugs or alcohol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital
Aarhus N, Vælg En Region, Stat Eller Provins., 8200
About this study
Official title: Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial
The KetMo study is an investigator-initiated, randomized, parallel group, double blinded trial investigating if ketamine as an adjunct to morphine improves pain treatment in the ED.
Patients in pain (assessed on NRS, 5 or more) will be randomized to low-dose ketamine or placebo as an adjunct to morphine. Patients with or without prior use of opioids will be randomized separately.
The primary outcome will be pain reduction, assessed on NRS, after 10 minutes. Secondary outcomes include pain reduction until 120 minutes after injection of study medicine, need for rescue opioid, side effects and patient- and provider satisfaction.
- Conditions
- Acute Pain, Opioid Use
- Being tested
- low dose ketamine, Placebo (saline)
- Keywords
- Low dose ketamine, Opioid use, Acute pain, Emergency Department
- 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.
low dose ketamineDrug
Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml
Placebo (saline)Drug
Isotonic Saline
| Study group | Role | What they receive |
|---|---|---|
| Intervention, low-dose ketamine | Experimental | Two 1 ml syringes with Esketamine (5 mg/ml) will be prepared and study drug will be administered as intravenous bolus dose, 0,1 mg/kg. The study drug will be administered after an intravenous morphine dose. Receives: Drug: low dose ketamine |
| Placebo | Placebo comparator | Two 1 ml syringes with saline will be prepared and study drug will be administered as intravenous dose, same volume as if Esketamine. The placebo drug will be administered after an intravenous morphine dose. Receives: Drug: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction after 10 minutes assessed on numeric rating scale, NRS
Numeric Rating Scale, 0-10
Measured: 10 minutes
Secondary outcomes (7)
Pain intensity assessed on numeric rating scale, NRS
Measured: 120 minutes
Need for rescue opioid
any kind of opioid
Measured: 120 minutes
Side effects
At each time point (10 min, 20 min, 30 min, 45 min, 60 min and 120) vital parameters are measured (Blood pressure, Respiratory Frequency, Saturation, Heart Rate) and the patient are asked if they experience nausea/vomiting, a dream like state/dissociation/out of body experience, anxiety or dizziness.
Besides a objective RASS score +4 to -5 (combative/very agitated/agitated/restless/aler and calm/drowsy/light sedation/moderate sedation/deep sedation/unarousable
Measured: 120 minutes
Patient satisfaction
Lickert scale
Measured: 120 minutes
Provider satisfaction
Lickert scale
Measured: 120 minutes
Comparison af pain reduction ( prior use of opioid vs no prior use of opioid
Measured: 120 minutes
Patient Rated Pain Relief
6 point lickert scale - worse pain, no pain relief, little pain relief, moderate pain relief, good pain relief, complete pain relief.
Measured: Patient are asked at timepoint 10 and timepoint 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start31 May 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Why it stopped: Not able to recruit opioid tolerant patients as expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Stine F Galili, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422001
- Sponsor's protocol ID
- KetMO
- Acronym
- KetMo
- Status last verified
- Sep 2023
- First submitted
- 27 May 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Six month after the publication of the last results, all de-identified individual patient data will be made available for data sharing
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05422001
- Acronym / sponsor ID
- KetMo / KetMO
- Conditions
- Acute Pain, Opioid Use
- Keywords
- Low dose ketamine, Opioid use, Acute pain, Emergency Department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able to recruit opioid tolerant patients as expected
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region, Aarhus University Hospital
- Study start
- 31 May 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- 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.
The KetMo study is an investigator-initiated, randomized, parallel group, double blinded trial investigating if ketamine as an adjunct to morphine improves pain treatment in the ED.
Patients in pain (assessed on NRS, 5 or more) will be randomized to low-dose ketamine or placebo as an adjunct to morphine. Patients with or without prior use of opioids will be randomized separately.
The primary outcome will be pain reduction, assessed on NRS, after 10 minutes. Secondary outcomes include pain reduction until 120 minutes after injection of study medicine, need for rescue opioid, side effects and patient- and provider satisfaction.
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 |
|---|---|---|
| Intervention, low-dose ketamine | Experimental | Drug: low dose ketamineTwo 1 ml syringes with Esketamine (5 mg/ml) will be prepared and study drug will be administered as intravenous bolus dose, 0,1 mg/kg. The study drug will be administered after an intravenous morphine dose. |
| Placebo | Placebo comparator | Drug: Placebo (saline)Two 1 ml syringes with saline will be prepared and study drug will be administered as intravenous dose, same volume as if Esketamine. The placebo drug will be administered after an intravenous morphine dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Emergency Department admission
- Age ≥ 18 years
- NRS ≥ 5
- Stable vital signs defined as systolic blood pressure ≥ 90 mmHg, heart rate between 60 and 150 per minute, respiratory rate between 8 and 26 per minute, oxygen saturation greater than or equal to 92%
Key exclusion criteria (11 listed)
- Initial management by trauma-team
- Systolic blood pressure ≥ 180mmHg, severe untreated arrhythmia, unstable angina, recent myocardial infarction (< 30 days), severe heart-failure (Ejection fraction < 40 %)
- Symptoms of untreated hyperthyroidism
- Cirrhosis with ascites
- Known/suspected pregnancy or breastfeeding
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 |
|---|---|---|
| low dose ketamineLow dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml | Drug | Intervention, low-dose ketamine |
| Placebo (saline)Isotonic Saline | Drug | Placebo |
Primary outcome
Pain reduction after 10 minutes assessed on numeric rating scale, NRS
Time frame: 10 minutes
Numeric Rating Scale, 0-10
7 secondary outcomes
Pain intensity assessed on numeric rating scale, NRS
Time frame: 120 minutes
Need for rescue opioid
Time frame: 120 minutes
Side effects
Time frame: 120 minutes
Patient satisfaction
Time frame: 120 minutes
Provider satisfaction
Time frame: 120 minutes
Comparison af pain reduction ( prior use of opioid vs no prior use of opioid
Time frame: 120 minutes
Patient Rated Pain Relief
Time frame: Patient are asked at timepoint 10 and timepoint 120
Results and safety
The study was stopped early (reason given: Not able to recruit opioid tolerant patients as expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Six month after the publication of the last results, all de-identified individual patient data will be made available for data sharing
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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.
Stine F Galili, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low dose ketamine in people with Acute Pain and Opioid Use, run by University of Aarhus at 1 site in Denmark.
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 11 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 26 Sep 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 Denmark. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Not able to recruit opioid tolerant patients as expected). Results are not available in the source record.
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?
Pain reduction after 10 minutes assessed on numeric rating scale, NRS (time frame: 10 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 26 Sep 2023.