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COMPLETED
NCT00454259
PHASE4

Fentanyl Ultra Low Doses Effects on the Nociceptive Threshold

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

Exaggerated pain and hyperalgesia are major issues after surgery and can lead to chronic pain. Opioid are parts of pain sensitization processes but remain absolutely necessary in the intraoperative period. NMDA receptor antagonists succeed in reducing this pain sensitization process. Recent studies show that in pain and opioid-experienced rats (POER) fentanyl ultra low doses do not induce analgesia, as observed in naive rats, but hyperalgesia. This is the first demonstration that a drug can induce opposite effect depending on individual history. We also observed a strong correlation between this hyperalgesic response in POER and the intensity of hyperalgesia they develop later, after inflammatory or surgical pain. The main aim of this study is to measure the dose effect response to fentanyl "ultra low doses" on human volunteer's nociceptive threshold, to determine if such an opposite response profile can be revealed.

Official title: Fentanyl Ultra Low Doses Effects on Human Volunteer's Nociceptive Threshold. Towards a Simple Pharmacological Test Able to Predict Pain Vulnerability, Post Operative Hyperalgesia Development Risk?

Key Details

Gender

MALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2007-03

Completion Date

2007-08

Last Updated

2026-05-14

Healthy Volunteers

Yes

Interventions

DRUG

Fentanyl/Placebo injection

Ultra low dose intravenous injection

Locations (1)

CHU de Bordeaux Département d'Anesthésie-Réanimation II

Pessac, Hôpital Cardiologique, France