No registrations found.
ID
Source
Brief title
Health condition
- ketamine
- nebulization
- pharmocokinetics
- analgesia
- side effects
Sponsors and support
Intervention
Outcome measures
Primary outcome
safety of procedure
Secondary outcome
analgesia, pharmakinetics ans hemodynamic effects (Blood pressure, cardiac output, heart rate
Background summary
The aim of this study is to investigate the efficacy and safety of nebulizing S-ketamine. Three different doses of nebulized S-ketamine will be administered. Arterial blood samples will be taken to measure pharmokinetic effect. The analgesic effect will be measured by two different pain tests (pressure and electrical test). Side effects will be evaluated by two questionnaires (Bowdle, and Bond&Lader)
Study objective
- Hypothesis#1 efficacy
We hypothesize that a quick onset, and a predictable dose-response, good adjustability of analgesia can be achieved with inhaled ketamine.
Hypothesis#2 safety
Inhalation of nebulized ketamine might lead to a fast onset of analgesia, with limited adverse events.
Study design
Analgesia:before nebulization, 18, 30, 60 and 80 minutes
after start of nebulization, pain relief to pressure pain will be
studied
pharmacokinetics: arterial blood samples (3 ml per sample) for ketamine and norketamine will be taken before nebulization/iv infusion and at specific time points during and after inhalation and iv treatment.
- Hemodynamics: Continuous cardiopulmonary monitoring
-Side effects will be inquired before start of nebulization, just after and every 20 minutes after nebulization. Side
effects will be measured using visual analog scales ranging from 0 to 10 cm of the Bowdle and Bond &Lader questionnaires.
Intervention
nebulazing ketamine
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Inclusion criteria
men/women 18-39years BMI <30kg/m2
Exclusion criteria
pulmonary disease, hypertensin, 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; concurrent participation in another trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5210 |
| NTR-old | NTR5358 |
| Other | NL53147.058.15 : P15.107 |