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Pain treatment in the Emergency Department

Phase 1
Conditions
Acute pain in the Emergency Department
MedDRA version: 20.1Level: LLTClassification code 10066714Term: Acute painSystem Organ Class: 100000004867
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2021-005116-64-DK
Lead Sponsor
Aarhus University Hospital, Department of Anesthesiology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
160
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

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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