NCT01260883

Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Months – 18 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Population kinetic analysis of ketorolac stereo-isomer concentrations after single dose given postoperatively in infants aged 2-18 months. Safety assessments of renal and hepatic function tests by blood tests before and after drug administration, urinalysis pre- and post-drug, continuous oximetry before and for 12 hours after drug. Morphine use between active drug groups and placebo group in the first 24 hours after surgery was assessed as a surrogate analgesic measure in these non-verbal infants. A modified infant pain scale was used to assure consistent pain management.

Conditions

• Postoperative Pain in Infants

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2000-05-01
• Primary completion: 2008-03-01
• Completion: 2010-12-01
• First posted: 2010-12-15
• Last updated: 2013-06-13
• Results posted: 2012-08-08

Locations

1 site across 1 country: United States