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

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ClinicalTrials.gov Identifier: NCT05422001
Recruitment Status : Recruiting
First Posted : June 16, 2022
Last Update Posted : June 16, 2022
Sponsor:
Collaborators:
Central Denmark Region
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE May 27, 2022
First Posted Date  ICMJE June 16, 2022
Last Update Posted Date June 16, 2022
Actual Study Start Date  ICMJE May 31, 2022
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2022)
Pain reduction after 10 minutes assessed on numeric rating scale, NRS [ Time Frame: 10 minutes ]
Numeric Rating Scale, 0-10
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2022)
  • Pain intensity assessed on numeric rating scale, NRS [ Time Frame: 120 minutes ]
  • Need for rescue opioid [ Time Frame: 120 minutes ]
    any kind of opioid
  • Side effects [ Time Frame: 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
  • Patient satisfaction [ Time Frame: 120 minutes ]
    Lickert scale
  • Provider satisfaction [ Time Frame: 120 minutes ]
    Lickert scale
  • Comparison af pain reduction ( prior use of opioid vs no prior use of opioid [ Time Frame: 120 minutes ]
  • Patient Rated Pain Relief [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED
Official Title  ICMJE Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED: a Randomized, Double-blinded Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pain
  • Opioid Use
Intervention  ICMJE
  • Drug: low dose ketamine
    Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml
  • Drug: Placebo (saline)
    Isotonic Saline
Study Arms  ICMJE
  • 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.
    Intervention: Drug: low dose ketamine
  • 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.
    Intervention: Drug: Placebo (saline)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2022)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stine F Galili, MD 20222240 s.galili@clin.au.dk
Contact: Lone Nikolajsen, Prof, Chair lone.nikolajsen@clin.au.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05422001
Other Study ID Numbers  ICMJE KetMO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Six month after the publication of the last results, all de-identified individual patient data will be made available for data sharing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Current Responsible Party University of Aarhus
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Aarhus
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Central Denmark Region
  • Aarhus University Hospital
Investigators  ICMJE
Principal Investigator: Stine F Galili, MD Aarhus University Hospital
PRS Account University of Aarhus
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP