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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 Surgery

Central 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 Surgery

Percent 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

Page last updated: August 23, 2015

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