12
Participants
Start Date
December 31, 2014
Primary Completion Date
April 30, 2015
Study Completion Date
September 30, 2015
Intranasal naloxone
Administer 0,1 ml 8 mg/ml naloxone intranasally, dose = 0,8 mg naloxone
Intramuscular naloxone
Administer 2 mL, dose intramuscular naloxone 0,8 mg
Remifentanil
Administer remifentanil intravenously by way of Target Control Infusion, Minto model at a target of 2,5 ng/ml. This to achieve a state of safe and predictable opioid influence to assess pharmacodynamic response to naloxone. After treatment of 4 participants protocol amended 22. january 2015 to reduce remifentanil target to 1,25 ng/ml in the next 4. In the last 4 participants the dose will be decided later, but not exceed 2,5 ng/ml.
Aptar Unidose
This is the spray device chosen, and its function in this setting (spray up side down) will be assessed by weighing the device before and after administration.
Department of Circulation and Medical Imaging, Trondheim
St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER