Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Information source: Seattle Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain in Infants
Intervention: Ketorolac Tromethamine 1 mg/kg (Drug); Ketorolac Tromethamine 0.5 mg/kg (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Seattle Children's Hospital Official(s) and/or principal investigator(s): Anne M. Lynn, MD, Principal Investigator, Affiliation: Seattle Children's Hospital
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.
Clinical Details
Official title: Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following SurgeryCentral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery
Secondary outcome: Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following SurgeryPercent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants
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.
Eligibility
Minimum age: 2 Months.
Maximum age: 18 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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)
Locations and Contacts
Seattle Children's Hospital, Seattle, Washington 98105, United States
Additional Information
Starting date: May 2000
Last updated: June 4, 2013
|