Clinical trial NCT01260883: Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Official title: Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain in Infants
Keywords: ketorolac pharmacokinetics
ketorolac stereo-isomers
infants
postoperative analgesia
safety
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2010-12-15
Enrollment: 77
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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)

Primary outcomes:
measure: Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery
timeFrame: 24 hours following surgery
measure: Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants
timeFrame: 24 hours after surgery
measure: Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants
timeFrame: 24 hours post surgery
measure: Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants
timeFrame: 24 hours after surgery
measure: Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants
timeFrame: 24 hours after surgery
measure: Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants
timeFrame: 24 hours after surgery
measure: Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants
timeFrame: 24 hours after surgery
measure: Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery
timeFrame: first day after surgery
measure: Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants
timeFrame: 12 hours after ketorolac or placebo infusion
measure: Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery
timeFrame: 24 hours after surgery
measure: Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Anne M. Lynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lynn AM, Bradford H, Kantor ED, Seng KY, Salinger DH, Chen J, Ellenbogen RG, Vicini P, Anderson GD. Postoperative ketorolac tromethamine use in infants aged 6-18 months: the effect on morphine usage, safety assessment, and stereo-specific pharmacokinetics. Anesth Analg. 2007 May;104(5):1040-51, tables of contents. doi: 10.1213/01.ane.0000260320.60867.6c.
citation: Lynn AM, Bradford H, Kantor ED, Andrew M, Vicini P, Anderson GD. Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. Paediatr Anaesth. 2011 Mar;21(3):325-34. doi: 10.1111/j.1460-9592.2010.03484.x. Epub 2010 Dec 29.