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

University of Aarhus (Other)
Overall Status
Recruiting ID
Central Denmark Region (Other), Aarhus University Hospital (Other)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: low dose ketamine
  • Drug: Placebo (saline)
Phase 4

Study Design

Study Type:
Anticipated Enrollment :
160 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Official Title:
Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial
Actual Study Start Date :
May 31, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention, low-dose ketamine

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.

Drug: low dose ketamine
Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml

Placebo Comparator: Placebo

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.

Drug: Placebo (saline)
Isotonic Saline

Outcome Measures

Primary Outcome Measures

  1. Pain reduction after 10 minutes assessed on numeric rating scale, NRS [10 minutes]

    Numeric Rating Scale, 0-10

Secondary Outcome Measures

  1. Pain intensity assessed on numeric rating scale, NRS [120 minutes]

  2. Need for rescue opioid [120 minutes]

    any kind of opioid

  3. 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

  4. Patient satisfaction [120 minutes]

    Lickert scale

  5. Provider satisfaction [120 minutes]

    Lickert scale

  6. Comparison af pain reduction ( prior use of opioid vs no prior use of opioid [120 minutes]

  7. 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.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 Aarhus University Hospital Aarhus N Vælg En Region, Stat Eller Provins. Denmark 8200

Sponsors and Collaborators

  • University of Aarhus
  • Central Denmark Region
  • Aarhus University Hospital


  • Principal Investigator: Stine F Galili, MD, Aarhus University Hospital

Study Documents (Full-Text)

More Information

Additional Information:


None provided.
Responsible Party:
University of Aarhus Identifier:
Other Study ID Numbers:
  • KetMO
First Posted:
Jun 16, 2022
Last Update Posted:
Jun 16, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Keywords provided by University of Aarhus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2022