Treatment of ketamine side effects using nitroprusside
- Conditions
- Chronic painTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-000550-37-NL
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Subjects of either sex (10 men/10 women), aged 18-39 years with a body mass index < 30 kg/m2.
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 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Severe medical disease including hypertension, liver/renal disease, neurological disorders, diaphragmatic hernia/pyrosis; (history of) psychiatric or neurological disease; pregnancy/lactation; allergy to study medication; (history of) illicit drug use/alcoholism.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the ability of NNP to prevent ketamine's psychotypical side effects;Secondary Objective: To assess pain relief from ketamine during NNP infusion;Primary end point(s): Psychedelic and negative effects are measured using visual analog scales ranging from 0 (no effect) to 10 cm (maximum effect) of the Bowdle and Bond & Ladder questionnaires;Timepoint(s) of evaluation of this end point: 15 min intervals during ketamine infusion
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 15 min intervals during ketamine infusion;Secondary end point(s): Response to pressure pain, electrical pain and heat pain