KetMo: Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED
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.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: 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.
Drug: low dose ketamine
Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml
|Placebo Comparator: 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.
Drug: Placebo (saline)
Primary Outcome Measures
- Pain reduction after 10 minutes assessed on numeric rating scale, NRS [10 minutes]
Numeric Rating Scale, 0-10
Secondary Outcome Measures
- Pain intensity assessed on numeric rating scale, NRS [120 minutes]
- Need for rescue opioid [120 minutes]
any kind of opioid
- Side effects [120 minutes]
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
- Patient satisfaction [120 minutes]
- Provider satisfaction [120 minutes]
- Comparison af pain reduction ( prior use of opioid vs no prior use of opioid [120 minutes]
- Patient Rated Pain Relief [Patient are asked at timepoint 10 and timepoint 120]
6 point lickert scale - worse pain, no pain relief, little pain relief, moderate pain relief, good pain relief, complete pain relief.
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%
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
Contacts and Locations
|1||Aarhus University Hospital||Aarhus N||Vælg En Region, Stat Eller Provins.||Denmark||8200|
Sponsors and Collaborators
- University of Aarhus
- Central Denmark Region
- Aarhus University Hospital
- Principal Investigator: Stine F Galili, MD, Aarhus University Hospital
Study Documents (Full-Text)