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

University of Aarhus

Status and phase: Terminated; Phase 4

Conditions: Opioid Use; Acute Pain

Treatments: Drug: Placebo (saline); Drug: low dose ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05422001

KetMO

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

Intervention, low-dose ketamine

Experimental group

Description:

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.

Treatment:

Drug: low dose ketamine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (saline)