NCT05422001

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	low dose ketamine	Low dose ketamine 0.1 mg/kg Product: Esketamin "Orifarm" 5 mg/ml
DRUG	Placebo (saline)	Isotonic Saline

Timeline

• Start date: 2022-05-31
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2022-06-16
• Last updated: 2023-09-26

Locations

1 site across 1 country: Denmark