Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

Phase 3 Completed 77 enrolled Seattle Children's Hospital University of Washington · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.

Timeline

Start: 2000-05
Primary completion: 2008-03
Completion: 2010-12

Publications

Results Lynn AM, Bradford H, Kantor ED, Seng KY, Salinger DH, Chen J, Ellenbogen RG, Vicini P, Anderson GD. Postoperative ketorolac tromethamine use in infants aged 6-18 months: the effect on morphine usage, safety assessment, and stereo-specific pharmacokinetics. Anesth Analg. 2007 May;104(5):1040-51, tables of contents. doi: 10.1213/01.ane.0000260320.60867.6c.
Results Lynn AM, Bradford H, Kantor ED, Andrew M, Vicini P, Anderson GD. Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. Paediatr Anaesth. 2011 Mar;21(3):325-34. doi: 10.1111/j.1460-9592.2010.03484.x. Epub 2010 Dec 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketorolac	Other / unclassified	0.5 mg/kg	Intravenous
Subject	Ketorolac	Other / unclassified	1 mg/kg	Intravenous

Indications

No indication recorded.