Pain — Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
Citation(s)
Ando K, Wallace MS, Braun J, Schulteis G Effect of oral mexiletine on capsaicin-induced allodynia and hyperalgesia: a double-blind, placebo-controlled, crossover study. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):468-74.
Cervero F, Gilbert R, Hammond RG, Tanner J Development of secondary hyperalgesia following non-painful thermal stimulation of the skin: a psychophysical study in man. Pain. 1993 Aug;54(2):181-9.
Eisenach JC, Hood DD, Curry R, Tong C Alfentanil, but not amitriptyline, reduces pain, hyperalgesia, and allodynia from intradermal injection of capsaicin in humans. Anesthesiology. 1997 Jun;86(6):1279-87.
Eisenach JC, Hood DD, Curry R Intrathecal, but not intravenous, clonidine reduces experimental thermal or capsaicin-induced pain and hyperalgesia in normal volunteers. Anesth Analg. 1998 Sep;87(3):591-6.
Wallace MS, Laitin S, Licht D, Yaksh TL Concentration-effect relations for intravenous lidocaine infusions in human volunteers: effects on acute sensory thresholds and capsaicin-evoked hyperpathia. Anesthesiology. 1997 Jun;86(6):1262-72.
Wallace, M S., et al., Concentration-effect relationship for intravenous alfentanil and ketamine infusions in human volunteers: Effects upon acute sensory thresholds and capsaicin evoked hyperpathia. J Pain, 2001. 2: p. A646.
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.