NCT00330343 - Clinical Trial References

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.

Citation(s)

Gan TJ, Ginsberg B, Glass PS, Fortney J, Jhaveri R, Perno R
Opioid-sparing effects of a low-dose infusion of naloxone in patient-administered morphine sulfate. Anesthesiology. 1997 Nov;87(5):1075-81.
Maxwell LG, Kaufmann SC, Bitzer S, Jackson EV Jr, McGready J, Kost-Byerly S, Kozlowski L, Rothman SK, Yaster M
The effects of a small-dose naloxone infusion on opioid-induced side effects and analgesia in children and adolescents treated with intravenous patient-controlled analgesia: a double-blind, prospective, randomized, controlled study. Anesth Analg. 2005 Apr;100(4):953-8.

The Optimal Dose of Prophylactic Naloxone in Ameliorating Opioid Induced Side Effects in Children and Adolescents Receiving Intravenous Patient Controlled Analgesia (IVPCA) Morphine for Moderate to Severe Pain: A Pharmacodynamic, Pharmacokinetic, and Pharmacogenetic Study

Details for clinical trial NCT00330343

Clinical trial NCT00330343 - References