NCT01557985 - 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)

Abdel-Rahman SM, Jacobs RF, Massarella J, Kauffman RE, Bradley JS, Kimko HC, Kearns GL, Shalayda K, Curtin C, Maldonado SD, Blumer JL
Single-dose pharmacokinetics of intravenous itraconazole and hydroxypropyl-beta-cyclodextrin in infants, children, and adolescents. Antimicrob Agents Chemother. 2007 Aug;51(8):2668-73. Epub 2007 May 21.
Bielsky A, Efrat R, Suresh S
Postoperative analgesia in neonates after major abdominal surgery: 'TAP' our way to success! Paediatr Anaesth. 2009 May;19(5):541-2. doi: 10.1111/j.1460-9592.2009.02988.x.
Christians U, Jacobsen W, Serkova N, Benet LZ, Vidal C, Sewing KF, Manns MP, Kirchner GI
Automated, fast and sensitive quantification of drugs in blood by liquid chromatography-mass spectrometry with on-line extraction: immunosuppressants. J Chromatogr B Biomed Sci Appl. 2000 Oct 1;748(1):41-53.
Frassetto L, Baluom M, Jacobsen W, Christians U, Roland ME, Stock PG, Carlson L, Benet LZ
Cyclosporine pharmacokinetics and dosing modifications in human immunodeficiency virus-infected liver and kidney transplant recipients. Transplantation. 2005 Jul 15;80(1):13-7.
Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C
The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
Zhang YL, Bendrick-Peart J, Strom T, Haschke M, Christians U
Development and validation of a high-throughput assay for quantification of the proliferation inhibitor ABT-578 using LC/LC-MS/MS in blood and tissue samples. Ther Drug Monit. 2005 Dec;27(6):770-8.

Single Dose Pharmacokinetics and Pharmacodynamics of Bupivacaine Following Transversus Abdominis Plane (TAP) Block in Neonates

Details for clinical trial NCT01557985

Clinical trial NCT01557985 - References