Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

PHASE3CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

May 31, 2000

Primary Completion Date

March 31, 2008

Study Completion Date

December 31, 2010

Conditions
Postoperative Pain in Infants
Interventions
DRUG

Ketorolac Tromethamine 1 mg/kg

Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

DRUG

Ketorolac Tromethamine 0.5 mg/kg

Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

DRUG

Placebo

Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

Trial Locations (1)

98105

Seattle Children's Hospital, Seattle

All Listed Sponsors
collaborator

University of Washington

OTHER

lead

Seattle Children's Hospital

OTHER

NCT01260883 - Ketorolac in Postoperative Infants: Pharmacokinetics and Safety | Biotech Hunter | Biotech Hunter