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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Central Denmark Region
• Treatments: Ketamine

Criteria

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