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

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT05422001

Collaborator

Central Denmark Region (Other), Aarhus University Hospital (Other)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

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
Acute Pain Opioid Use	Drug: low dose ketamine Drug: Placebo (saline)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

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

Pain reduction after 10 minutes assessed on numeric rating scale, NRS [10 minutes]
Numeric Rating Scale, 0-10

Secondary Outcome Measures

Pain intensity assessed on numeric rating scale, NRS [120 minutes]
Need for rescue opioid [120 minutes]
any kind of opioid
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
Patient satisfaction [120 minutes]
Lickert scale
Provider satisfaction [120 minutes]
Lickert scale
Comparison af pain reduction ( prior use of opioid vs no prior use of opioid [120 minutes]
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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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%

Exclusion Criteria:

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