To asses the effect of opioid receptor blockade on fentnayl induced pain relief
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain relief using two pain assays (heat pain and electrical pain)
Secondary outcome
-
Background summary
Previously, (Protocol P04.067) we showed that iv fentanyl produces analgesic
responses in the heat pain test. See also figure 1. This stands in sharp
contrast with data from a different protocol (P05.022) in which we observed
that another opioid (M6G) caused hyperalgesic responses using the heat pain
test (see also figure 2).
It may well be that opioids cause a balanced effect via activation of opioid
and non-opioid receptors. The latter possibly being NMDA-receptors. While the
analgesic effect my dominate in some opioids (due to activation of opioid
receptors with little activation of NMDA receptors), other opioids may cause
hyperalgesic responses due to a shift in the balance towards the NMDA-receptor
activation.
In this study we will focus on this latter hypothesis. If true, all opioids
will cause hyperalgesic responses when the opioid receptor is blocked. We will
perform fentanyl analgesic responses with and without naloxone infusion.
Study objective
To asses the effect of opioid receptor blockade on fentnayl induced pain relief
Study design
Double blinded, parallel, randomized. 2 groups: A: Fentanyl vs fentanyl +
naloxone// B: placebo vs naloxone + placebo
Intervention
Infusion of opioid (fentanyl) and its antagonist (naloxone)
Study burden and risks
Little to no risk. Side effect: sedation/nausea
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Healthy volunteers, aged 18-45 yrs
Exclusion criteria
Obesity (BMI > 30);
Presence of medical disease (heart-, lung-, liver-, kidney-, neurological disease; diabetes m.; pyrosis; diaphragmatic hernia);
Presence of psychiatric disease;
History of chronic alcohol or drug use;
Allergy to study medications;
Possibility of pregnancy;
Lactation.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2007-006113-17-NL |
| CCMO | NL20439.058.07 |