CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 77 enrolled
Drug / intervention
Ketorolac Tromethamine 1 mg/kg +2 moredrug
Likely dose
Ketorolac Tromethamine 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01260883
NCT01260883Phase 3Completed
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Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

Seattle Children's Hospital·interventional·Posted Dec 15, 2010·Updated Jun 13, 2013

In Brief

A Phase 3 clinical trial evaluating Ketorolac Tromethamine 1 mg/kg, Ketorolac Tromethamine 0.5 mg/kg, and 1 other intervention for Postoperative Pain in Infants. Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain in Infants
CountriesUnited States
CollaboratorsUniversity of Washington

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 15, 2010
Enrollment StartMay 1, 2000
Primary CompletionMar 1, 2008
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 15.5 years ago

Interventions

Ketorolac Tromethamine 1 mg/kgdrug

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.

Ketorolac Tromethamine 0.5 mg/kgdrug

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.

Placebodrug

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.