Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02684669
Eligibility Criteria:
Inclusion Criteria:
* Healthy male
* Signed informed consent
* Urin-sample without traces of opioids (morphine, methadone, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphone, dextro-methorphan)
* ASA I
* Body mass index (BMI): 18 \< BMI \< 30 kg/sq.m
In addition Days 2-4:
• Secondary hyperalgesia areas 1 hr after a burn injury belonging to the upper quartile (Q3: high-sensitizers \[n = 20\]) or the lower quartile (Q1: low-sensitizers \[n = 20\]) The selection is made during a separate test day (Day 0 \[n = 80\]).
Exclusion Criteria:
* Participants, who do not speak or understand Danish
* Participants, who cannot cooperate with the investigation
* Allergic reaction against morphine or other opioids (including naloxone)
* Abuse of alcohol or drugs - according to investigator's evaluation
* Use of psychotropic drugs
* Neurologic or psychiatric disease
* Signs of neuropathy in the examination region
* Previous severe trauma to the lower legs with sequelae
* Scarring or tattoos in the examination areas
* Chronic pain condition
* Regular use of analgesic drugs
* Use of prescription drugs one week before the trial
* Use of over-the-counter (OTC) drugs 48 hours before the trial
* Does not develop measurable secondary hyperalgesia areas after BI
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02684669
Study Brief:
Protocol Section:
NCT02684669