A Phase 4 interventional study of low dose ketamine and Placebo (saline) in Acute Pain and Opioid Use, sponsored by University of Aarhus. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 116 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: low dose ketamine
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.
Drug: Placebo (saline)
Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml
Isotonic Saline
Pain reduction after 10 minutes assessed on numeric rating scale, NRS
Numeric Rating Scale, 0-10
Time frame: 10 minutes
Pain intensity assessed on numeric rating scale, NRS
Time frame: 120 minutes
Need for rescue opioid
any kind of opioid
Time frame: 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
Time frame: 120 minutes
Patient satisfaction
Lickert scale
Time frame: 120 minutes
Provider satisfaction
Lickert scale
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
6 point lickert scale - worse pain, no pain relief, little pain relief, moderate pain relief, good pain relief, complete pain relief.
Time frame: Patient are asked at timepoint 10 and timepoint 120
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Six month after the publication of the last results, all de-identified individual patient data will be made available for data sharing
Supporting information: Study protocol, Sap, Analytic code
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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University of Aarhus