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

Opioid Use Clinical Trial

— KetMo  

Official title:

Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05422001
• Other study ID #: KetMO
• Status: Terminated
• Phase: Phase 4
• Start date: May 31, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: September 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use

Intervention

Drug:
• low dose ketamine
Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml
• Placebo (saline)
Isotonic Saline

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N	Vælg En Region, Stat Eller Provins.

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Central Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction after 10 minutes assessed on numeric rating scale, NRS	Numeric Rating Scale, 0-10	10 minutes
Secondary	Pain intensity assessed on numeric rating scale, NRS		120 minutes
Secondary	Need for rescue opioid	any kind of opioid	120 minutes
Secondary	Side effects	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	120 minutes
Secondary	Patient satisfaction	Lickert scale	120 minutes
Secondary	Provider satisfaction	Lickert scale	120 minutes
Secondary	Comparison af pain reduction ( prior use of opioid vs no prior use of opioid		120 minutes
Secondary	Patient Rated Pain Relief	6 point lickert scale - worse pain, no pain relief, little pain relief, moderate pain relief, good pain relief, complete pain relief.	Patient are asked at timepoint 10 and timepoint 120

External Links

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