Status:
COMPLETED
Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
University of Washington
Conditions:
Postoperative Pain in Infants
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief 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 ...
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 blo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01260883
Start Date
May 1 2000
End Date
December 1 2010
Last Update
June 13 2013
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105