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

Primary Purpose

Acute Pain, Opioid Use

Status

Terminated

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

low dose ketamine

Placebo (saline)

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Low dose ketamine, Opioid use, Acute pain, Emergency Department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention, low-dose ketamine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Numeric Rating Scale, 0-10

Secondary Outcome Measures

Pain intensity assessed on numeric rating scale, NRS

Need for rescue opioid

any kind of opioid

Side effects

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

Lickert scale

Provider satisfaction

Lickert scale

Comparison af pain reduction ( prior use of opioid vs no prior use of opioid

Patient Rated Pain Relief

6 point lickert scale - worse pain, no pain relief, little pain relief, moderate pain relief, good pain relief, complete pain relief.

Full Information

NCT ID

NCT05422001

First Posted

May 27, 2022

Last Updated

September 21, 2023

Sponsor

University of Aarhus

Collaborators

Central Denmark Region, Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05422001

Brief Title

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

Acronym

KetMo

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Terminated

Why Stopped

Not able to recruit opioid tolerant patients as expected

Study Start Date

May 31, 2022 (Actual)

Primary Completion Date

August 15, 2023 (Actual)

Study Completion Date

August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Central Denmark Region, Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain, Opioid Use

Keywords

Low dose ketamine, Opioid use, Acute pain, Emergency Department

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention, low-dose ketamine

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

low dose ketamine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo (saline)

Intervention Description

Isotonic Saline

Primary Outcome Measure Information:

Title

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

Description

Numeric Rating Scale, 0-10

Time Frame

10 minutes

Secondary Outcome Measure Information:

Title

Pain intensity assessed on numeric rating scale, NRS

Time Frame

120 minutes

Title

Need for rescue opioid

Description

any kind of opioid

Time Frame

120 minutes

Title

Side effects

Description

Time Frame

120 minutes

Title

Patient satisfaction

Description

Lickert scale

Time Frame

120 minutes

Title

Provider satisfaction

Description

Lickert scale

Time Frame

120 minutes

Title

Comparison af pain reduction ( prior use of opioid vs no prior use of opioid

Time Frame

120 minutes

Title

Patient Rated Pain Relief

Description

6 point lickert scale - worse pain, no pain relief, little pain relief, moderate pain relief, good pain relief, complete pain relief.

Time Frame

Patient are asked at timepoint 10 and timepoint 120

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stine F Galili, MD

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus N

State/Province

Vælg En Region, Stat Eller Provins.

ZIP/Postal Code

8200

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Links:

URL

https://recem.au.dk/ketmo

Description

Related Info

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

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