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TerminatedPhase 4

Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED

NCT05422001 · KetMo · University of Aarhus

Closed to entry
Status
Not accepting participants
Phase 4
Phase
116
Target enrolment
1
Study sites
Outside the US

What it is testing

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. 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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Pain reduction after 10 minutes assessed on numeric rating scale, NRS

    Measured over 10 minutes

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Emergency Department admission 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: 1. Initial management by trauma-team 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

Where

1 study site

FacilityCityRegionCountry
Aarhus University HospitalAarhus NVælg En Region, Stat Eller Provins.Denmark

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05422001 on ClinicalTrials.gov →

Last updated in the registry 2023-09-26. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits