Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

Completed · Phase 3 · Has a placebo group

Conditions studied: Postoperative Pain in Infants

In brief

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.

Key facts

Study ID

NCT01260883

Run by

Seattle Children's Hospital

People needed

77

Starts

2000-05-01

Expected to finish

2010-12-01

Last updated by the study team

2013-06-13

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, < 6 months

You may not qualify if…

• Bleeding history in infant or family
• Coagulopathy
• Gastrointestinal bleeding history
• Renal or hepatic disease assessed by history and by pre-drug blood tests
• Premature birth (<36 weeks gestation)

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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