An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals (FEN001)
This study seeks to determine the suitable doses of fentanyl with acceptable adverse effect and safety profile in opioid-dependent patients. The investigators anticipate that a well tolerated dose of fentanyl which produces demonstrable analgesia will be found and will be related to the patient's maintenance opioid dose.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals|
- Attainment of analgesia [ Time Frame: Within 2 hours after starting the infusion ] [ Designated as safety issue: No ]Attainment of analgesia as evidenced by having the cold pain tolerance test reading to twice the baseline value or reaching the absolute value of 2 minutes.
- Pupillometry [ Time Frame: Within 2 hours after infusion starts ] [ Designated as safety issue: Yes ]The pupil diameter will be measured every 30 minutes during the infusion.
- Saccadic eye movement [ Time Frame: Within 2 hours after infusion starts ] [ Designated as safety issue: No ]The average peak velocity of the saccadic eye movement will be measured every half an hour for 2 hours.
- Morphine Benzedrine Group Scale [ Time Frame: Within 2 hours after infusion starts ] [ Designated as safety issue: Yes ]This paper test will take 3 minutes to complete and will measure the degree of euphoria.
- Electroencephalography (EEG) [ Time Frame: Within 2 hours after infusion starts ] [ Designated as safety issue: No ]The delta, theta and alpha Fz-Cz and Pz-Oz activity will be measured every 30 minutes during the infusion.
- Subjective Opioid Withdrawal Scale [ Time Frame: Within 1 hour after infusion stops ] [ Designated as safety issue: Yes ]This paper test will take 3 minutes to complete and will measure the degree of withdrawal. It will be done at 15, 30 and 60 minutes post infusion.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Intravenous infusion using STANPUMP
Fentanyl is a synthetic opiate with a (clinical) potency of 50 to 100 times that of morphine. Because of its high lipid solubility, fentanyl has a rapid onset of action and a relatively short duration of action. Fentanyl is one of the most widely used agents in the synthetic opioids family. Being a pure agonist with no active metabolites, it is highly suitable for use in patients with opioid tolerance. It can be used outside of an intensive-care clinical environment.
Evidence-based guidelines for clinicians on which agents to use, what doses should be considered and whether treatment doses are related to the dose and the pharmacological properties of the maintenance opioid are lacking, but needed. This study seeks to determine the suitable doses of fentanyl required in opioid-tolerant patients, which are able to overcome the tolerance and hyperalgesia while maintaining an acceptable therapeutic index. The importance of this study is that it has the potential to improve acute pain management in the opioid-tolerant population.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358500
|Contact: Paul E Rolan||+61882222712|
|Australia, South Australia|
|PARC, Royal Adelaide Hospital||Recruiting|
|Adelaide, South Australia, Australia, 5000|
|Contact: Rolan firstname.lastname@example.org|
|Principal Investigator: Paul E Rolan|
|Principal Investigator:||Paul E Rolan, MD||University of Adelaide|