Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED
NCT ID: NCT05422001
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
116 participants
INTERVENTIONAL
2022-05-31
2023-08-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention, low-dose ketamine
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.
low dose ketamine
Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml
Placebo
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.
Placebo (saline)
Isotonic Saline
Interventions
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low dose ketamine
Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml
Placebo (saline)
Isotonic Saline
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. NRS ≥ 5
4. 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%
Exclusion Criteria
2. Systolic blood pressure ≥ 180mmHg, severe untreated arrhythmia, unstable angina, recent myocardial infarction (\< 30 days), severe heart-failure (Ejection fraction \< 40 %)
3. Symptoms of untreated hyperthyroidism
4. Cirrhosis with ascites
5. Known/suspected pregnancy or breastfeeding
6. Patients for whom consent is not obtainable or psychiatric forced treatment.
7. Previously enrolled in the trial
8. Psychiatric illness prior to admission defined as prior psychosis/schizophrenia
9. Untreated diagnosed glaucoma
10. Known hypersensitivity to ketamine or to any excipient or prior use of ketamine with a negative experience (i.e. hallucinations)
11. Patient clearly influenced by drugs or alcohol
18 Years
ALL
No
Sponsors
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Central Denmark Region
OTHER
Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Stine F Galili, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus N, Vælg En Region, Stat Eller Provins., Denmark
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Latest amendment
Document Type: Statistical Analysis Plan: Updated statistical analysis plan before unblinding
Related Links
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Related Info
Other Identifiers
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KetMO
Identifier Type: -
Identifier Source: org_study_id
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