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

NCT05422001 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-09-26

No results posted yet for this study

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.

Conditions

  • Acute Pain
  • Opioid Use

Interventions

DRUG

low dose ketamine

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

DRUG

Placebo (saline)

Isotonic Saline

Sponsors & Collaborators

  • Central Denmark Region

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Stine F Galili, MD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-08-15
Completion
2023-08-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422001 on ClinicalTrials.gov