Clinical trial NCT05422001: Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED
Official title: Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Pain
Opioid Use
Keywords: Low dose ketamine
Opioid use
Acute pain
Emergency Department
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: Aarhus University Hospital
First posted: 2022-06-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain reduction after 10 minutes assessed on numeric rating scale, NRS
timeFrame: 10 minutes
Secondary outcomes:
measure: Pain intensity assessed on numeric rating scale, NRS
timeFrame: 120 minutes
measure: Need for rescue opioid
timeFrame: 120 minutes
measure: Side effects
timeFrame: 120 minutes
measure: Patient satisfaction
timeFrame: 120 minutes
measure: Provider satisfaction
timeFrame: 120 minutes
measure: Comparison af pain reduction ( prior use of opioid vs no prior use of opioid
timeFrame: 120 minutes
measure: Patient Rated Pain Relief
timeFrame: Patient are asked at timepoint 10 and timepoint 120
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
state: Vælg En Region, Stat Eller Provins.
Study officials:
affiliation: Aarhus University Hospital
name: Stine F Galili, MD
role: PRINCIPAL_INVESTIGATOR
References: