Acute Pain, Opioid Use
Conditions
Keywords
Low dose ketamine, Opioid use, Acute pain, Emergency Department
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 (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.
Interventions
Low dose ketamine 0.1 mg/kg Product: Esketamin Orifarm 5 mg/ml
DRUGPlacebo (saline)
Isotonic Saline
Sponsors
Central Denmark Region
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction after 10 minutes assessed on numeric rating scale, NRS | 10 minutes | Numeric Rating Scale, 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Lickert scale |
| Pain intensity assessed on numeric rating scale, NRS | 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. |
| Provider satisfaction | 120 minutes | Lickert scale |
Countries
Denmark
Outcome results
None listed