Pain induced in healthy volunteers MedDRA version: 9.1 Level: LLT Classification code 10066714 Term: Acute pain
Conditions
Interventions
Trade Name: Ketanest
Product Name: ketanest
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: KETAMINE
CAS Number: 6740881
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
LUMC
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy male volunteers in the age of 18-45 years 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Obesity (BMI > 30); Presence of medical disease (heart-, lung-, liver-, kidney-, neurologic disease; diabetes m.; pyrosis; diaphragmatic hernia); Presence of psychiatric disease; History of chronic alcohol or illicit drug use; Allergy to study medications; Color blindness; Use of contact lenses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the contribution of norketamine to ketamine's antinociceptive properties;Secondary Objective: To assess the contribution of norketamine to ketamine's cognitive effects;Primary end point(s): Pain relief Response to cognitive tests sedation cardiovascular changes | — |
Countries
Netherlands
Outcome results
None listed