Acute pain in the Emergency Department MedDRA version: 20.1 Level: LLT Classification code 10066714 Term: Acute pain System Organ Class: 100000004867
Conditions
Interventions
Trade Name: S-ketamin "Pfizer"
Pharmaceutical Form: Injection
INN or Proposed INN: Esketamine
Current Sponsor code: 16092021
Other descriptive name: ESKETAMINE HYDROCHLORIDE
Concentration unit: mg/ml
Sponsors
Aarhus University Hospital, Department of Anesthesiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Emergency Department admission 2) Age = 18 years 3) NRS = 5 4) Stable vital signs defined as systolic blood pressure = 90 mmHg, heart rate between 50 and 150 per minute, respiratory rate between 8 and 30 per minute, oxygen saturation greater than or equal to 92%. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) Initial management by trauma-team 2) Systolic blood pressure = 180mmHg, severe untreated arrhythmia, unstable angina, recent myocardial infarction (< 30 days), severe heart-failure (Ejection fraction < 40 %) 3) Symptoms of untreated hyperthyroidism 4) Cirrhosis with ascites 5) Known/suspected pregnancy or breastfeeding 6) Patients for whom consent is not obtainable or psychiatric forced treatment. 7) Previously enrolled in the trial 8) Psychiatric illness prior to admission defined as prior psychosis/schizophrenia 9) Untreated diagnosed glaucoma 10) Known hypersensitivity to ketamine or to any excipient or prior use of ketamine with a negative experience (i.e. hallucinations) 11) Patient clearly influenced by drugs or alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy and safety of IV Low-dose ketamine as an adjunct to IV morphine for the treatment of severe acute pain in the Emergency Department ;Secondary Objective: To determine the need of rescue opioid within 30, 60 and 120 min, side effects, patients satisfaction, provider satisfaction and to compare the effect in two groups of patients; patients with a prior use of opioid and patients without. ;Primary end point(s): The primary outcome measurement is pain reduction after 10 min assessed on NRS;Timepoint(s) of evaluation of this end point: 10 minutes after study medication is injected | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Need of rescue opioid within 30, 60 and 120 min. 2) Pain intensity after 20, 30, 40, 50, 60 and 120 min measured on NRS 3) Side effects 4) Patients Satisfaction 5) Provider Satisfaction Score 6) Comparison of pain reduction in the two groups ( prior opioid/no prior opioid ;Timepoint(s) of evaluation of this end point: 1) Need of rescue opioid within 30, 60 and 120 min. Time points 2) Pain intensity after 20, 30, 40, 50, 60 and 120 min measured on NRS 3) Side effects after 20, 30, 40, 50, 60 and 120 min 4) Patients Satisfaction after 120 min 5) Provider Satisfaction Score after 120 min 6) Comparison of pain reduction in the two groups ( prior opioid/no prior opioid | — |
Countries
Denmark
Contacts
Public ContactLone Nikolajsen
Aarhus University Hospital, Department of Anesthesiology
Outcome results
None listed