Abstract | BACKGROUND: OBJECTIVE: DESIGN: Single site, phase 1, double-blind, placebo-controlled, randomised crossover study. SETTING: University Hospital, Germany from January 2012 to April 2012. PARTICIPANTS: Twenty-one healthy male volunteers. INTERVENTIONS: MAIN OUTCOME MEASURES: Areas of pin-prick hyperalgesia, areas of touch-evoked allodynia and pain intensity on a visual analogue scale were assessed repeatedly for 160 min. RESULTS: Data from 20 volunteers were analysed. There were significant treatment and treatment-by-time effects regarding areas of hyperalgesia (P < 0.001). After the treatment period, the area of hyperalgesia was significantly reduced (P < 0.001) in the tested drug and in the gas active control (30.6 ± 9.25 and 24.4 ± 7.3 cm2, respectively) compared with remifentanil (51.0 ± 17.0 cm2). There was also a significant difference between the gas active control and the tested drug sessions (P < 0.001). For the area of allodynia and pain rating, results were consistent with the results for hyperalgesia. CONCLUSIONS: TRIAL REGISTRATION: EudraCT-No.: 2011-000966-37.
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Authors | Andreas Wehrfritz, Marcus Bauer, Nathalie Noel, Juan Fernando Ramirez-Gil, Harald Ihmsen, Johannes Prottengeier, Jürgen Schüttler, Baptiste Bessiere |
Journal | European journal of anaesthesiology
(Eur J Anaesthesiol)
Vol. 38
Issue 12
Pg. 1230-1241
(12 01 2021)
ISSN: 1365-2346 [Electronic] England |
PMID | 34735395
(Publication Type: Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2021 European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited. |
Chemical References |
- Analgesics, Opioid
- Piperidines
- Nitrous Oxide
- Remifentanil
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Topics |
- Analgesics, Opioid
- Double-Blind Method
- Healthy Volunteers
- Humans
- Hyperalgesia
(chemically induced, diagnosis, drug therapy)
- Male
- Nitrous Oxide
- Pain, Postoperative
- Piperidines
(adverse effects)
- Remifentanil
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