Status:
TERMINATED
Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Central Denmark Region
Aarhus University Hospital
Conditions:
Acute Pain
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05422001
Start Date
May 31 2022
End Date
August 15 2023
Last Update
September 26 2023
Active Locations (1)
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1
Aarhus University Hospital
Aarhus N, Vælg En Region, Stat Eller Provins., Denmark, 8200