Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00454259 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Fentanyl Ultra Low Doses Effects on the Nociceptive Threshold

Study acronym: FENTANULD
StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications: 12 to 13v4 See this version in full on ClinicalTrials.gov ↗
  2. Publications: 13 to 12v3 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Completed Primary completion date: Aug 2007 · Study completion date changed from estimate of Jul 2007 to Aug 2007 · Interventions: fentanyl (Drug) to Fentanyl/Placebo injection (Drug) · 3 morev2 Show 6 more changesShow less
    • Primary completion date: Aug 2007
    • Study completion date changed from estimate of Jul 2007 to Aug 2007
    • Interventions: fentanyl (Drug) to Fentanyl/Placebo injection (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated
    • Study arms: 0 to 4
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00454259
Lead Sponsor University Hospital, Bordeaux
Conditions Pain, Postoperative
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov