NCT05422001

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

May 27, 2022

Last Update Submit

September 21, 2023

Conditions

Acute PainOpioid Use

Keywords

Low dose ketamineOpioid useAcute painEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Pain reduction after 10 minutes assessed on numeric rating scale, NRS

    Numeric Rating Scale, 0-10

    10 minutes

Secondary Outcomes (7)

  • Pain intensity assessed on numeric rating scale, NRS

    120 minutes

  • Need for rescue opioid

    120 minutes

  • Side effects

    120 minutes

  • Patient satisfaction

    120 minutes

  • Provider satisfaction

    120 minutes

  • +2 more secondary outcomes

Study Arms (2)

Intervention, low-dose ketamine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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)

Interventions

low dose ketamineDRUG

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

Intervention, low-dose ketamine
Placebo (saline)DRUG

Isotonic Saline

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Department admission
  • Age ≥ 18 years
  • NRS ≥ 5
  • 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%

You may not qualify if:

  • Initial management by trauma-team
  • Systolic blood pressure ≥ 180mmHg, severe untreated arrhythmia, unstable angina, recent myocardial infarction (\< 30 days), severe heart-failure (Ejection fraction \< 40 %)
  • Symptoms of untreated hyperthyroidism
  • Cirrhosis with ascites
  • Known/suspected pregnancy or breastfeeding
  • Patients for whom consent is not obtainable or psychiatric forced treatment.
  • Previously enrolled in the trial
  • Psychiatric illness prior to admission defined as prior psychosis/schizophrenia
  • Untreated diagnosed glaucoma
  • Known hypersensitivity to ketamine or to any excipient or prior use of ketamine with a negative experience (i.e. hallucinations)
  • Patient clearly influenced by drugs or alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, Vælg En Region, Stat Eller Provins., 8200, Denmark

Location

Related Links

MeSH Terms

Conditions

Acute PainEmergencies

Interventions

KetamineSodium Chloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Stine F Galili, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 16, 2022

Study Start

May 31, 2022

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Six month after the publication of the last results, all de-identified individual patient data will be made available for data sharing

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

DK(1)