The effect of remifentanil on the reversal of established sunburn-induced hyperalgesia in human volunteers.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Trade Name: Ultiva Product Name: Remifentanil Product Code: N01AH06 Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: This is a volunteer study in healthy volunteers. Pain research, reversal of hyperalgesia by IMP is studied PRIMARY OUTCOME: Main Objective: To study the reversal of established hyperalgesia; The main outcome variable will be: area of pin prick hyperalgesia Primary end point(s): Area of pinprick hyperalgesia 6 hours after discontinuation of IMP Secondary Objective: To study the reversal effect on additional outcome variables for mechanical hyperalgesia will be:; Stimulus response (SR‐) function to a set of modified rigid von Frey filaments, area of dynamic allodynia to brush. Heat pain threshold within the area of mechanical hyperalgesia will serve as additional outcome variable. INCLUSION CRITERIA: • Men or women, aged between 19 and 40 years • Body mass index between 15th and 85th percentile • Normal findings in the medical history and physical examination • Drug free for 1 week prior to the study day 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: caf8546dfe2d65399e0cee281a9224a563b2d9dd
First added on: Aug 22, 2024