MedTrace Logo

Fentanyl Ultra Low Doses Effects on the Nociceptive Threshold

NCT00454259 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Fentanyl/Placebo injection

Ultra low dose intravenous injection

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Philippe RICHEBE, Dr · University Hospital, Bordeaux

  • Gérard JANVIER, PHD · University Hospital, Bordeaux

  • Claude DUBRAY, PHD · University Hospital, Bordeaux

  • Alain ESCHALIER, PHD · University Hospital, Bordeaux

  • jean DUALE CHRISTIAN, Dr · University Hospital, Bordeaux

  • Gisèle PICKERING, Dr · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454259 on ClinicalTrials.gov