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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketorolac 1 mg/kg | Experimental | ketorolac 1 mg/kg iv given by 10 min infusion |
|
| ketorolac 0.5 mg/kg | Active Comparator | ketorolac 0.5 mg/kg iv given by 10 min infusion |
|
| placebo | Sham Comparator | placebo group received D5W 10 min infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine 1 mg/kg | Drug | Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery | stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM) | 24 hours following surgery |
| Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants | stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants | 24 hours after surgery |
| Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants | peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM) | 24 hours post surgery |
| Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants | half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery | 24 hours after surgery |
| Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants | stereo-specific ketorolac clearance by population-based analysis (NONMEM) | 24 hours after surgery |
| Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants | population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery | 24 hours after surgery |
| Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery | total morphine given intravenously in the 12 hours following receiving intravenous ketorolac or placebo | first day after surgery |
| Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne M. Lynn, MD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17456651 | Result | 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. | |
| 21199130 |
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If screening lab studies (blood urea nitrogen [BUN], creatinine, liver transaminase concentrations, urinalysis) were abnormal infants were excluded. If postoperative concerns precluded blood sampling or if sampling intravenous (iv) catheters did not function, infants were excluded.Of 77 infants screened, 51 infants started study
Infants less than 18 months of age, having surgery requiring inpatient admission, from 2001 through 2008, with normal renal and liver function, not on chronic medication , not prematurely born, were selected.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac 1 mg/kg Intravenous | intravenous infusion over 10 minutes |
| FG001 | Ketorolac 0.5 mg/kg Intravenous | intravenous infusion over 10 minutes |
| FG002 | Dextrose 5% in Water (D5W) | intravenous infusion over 10 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac 1 mg/kg Intravenous | intravenous infusion over 10 minutes |
| BG001 | Ketorolac 0.5 mg/kg Intravenous | intravenous infusion over 10 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery | stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM) | of 25 infants aged 2-6 months enrolled, 11 were excluded. 8 received drug, 6 received placebo; this is a subset of the 77 enrolled infants (aged 2-18 months) of whom 51 completed the study. Infants receiving drug at 0.5 or 1 mg/kg were reported together, since no difference in drug handling was seen. | Posted | Mean | Standard Error | ml/min | 24 hours following surgery |
|
24 hours following surgery, monitoring for oximetry, blood loss, renal and liver function tests were done after drug infusion (active drug or placebo)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketorolac 1 mg/kg Intravenous | intravenous infusion over 10 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Lynn MD | Seattle Children's Hospital | 206 987-2518 | anne.lynn@seattlechildrens.org |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Ketorolac Tromethamine 0.5 mg/kg | Drug | Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments. |
|
|
| Placebo | Drug | Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments. |
|
|
population-based analysis of ketorolac stereo-isomers |
| 24 hours after surgery |
| Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery | noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants | 24 hours after surgery |
continuous oximetry monitoring of room air saturation was collected for 12 hours after intravenous infusion of ketorolac or placebo |
| 12 hours after ketorolac or placebo infusion |
| Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery | total amount of morphine given for 12 hours after ketorolac or placebo infusion in 6-18 month old infants after surgery | 24 hours after surgery |
| Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants | continuous oximetry monitoring for 12 hours after ketorolac or placebo intravenous infusion in 6-18 month old infants after surgery | 24 hours after surgery |
| 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. |
| BG002 | Dextrose 5% in Water (D5W) | intravenous infusion over 10 minutes |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | while 77 infants were enrolled, exclusions during screening or lack of intravenous access precluding blood sampling eliminated 26 infants. Gender data was not collected for infants not randomized to receive drug or placebo. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| R+ Ketorolac Clearance |
stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM) |
| OG002 | Placebo | stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM) |
|
|
| Primary | Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants | stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants | infants enrolled but did not complete protocol if abnormal laboratory studies or intravenous catheters were not functioning prior to study drug infusion. Of 77 enrolled, 51 completed study; of the 33 given ketorolac,8 were aged 2-6 months. Doses of 0.5 or 1 mg/kg were handled similarly so reported together. | Posted | Mean | Standard Error | ml | 24 hours after surgery |
|
|
|
| Primary | Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants | peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM) | 25 infants aged 2-6 months enrolled; 11 excluded for no sampling intravenous access. 8 infants received drug, 6 received placebo. No difference in analysis of doses of 0.5 or 1 mg/kg so reported together. | Posted | Mean | Standard Deviation | ml | 24 hours post surgery |
|
|
|
| Primary | Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants | half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery | total infants enrolled was 77; 26 were excluded before study procedures began. Of 51 infants completing the study, 8 infants aged 2-6 months received drug.No difference in analysis at doses of 0.5 or 1 mg/kg so reported together. | Posted | Mean | Standard Error | min | 24 hours after surgery |
|
|
|
| Secondary | Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery | total morphine given intravenously in the 12 hours following receiving intravenous ketorolac or placebo | 25 infants enrolled but 11 excluded. 8 received ketorolac, 6 placebo. total morphine given over 12 hours following infusion collected | Posted | Mean | Standard Deviation | mg/kg | first day after surgery |
|
|
|
| Secondary | Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants | continuous oximetry monitoring of room air saturation was collected for 12 hours after intravenous infusion of ketorolac or placebo | 25 infants aged 2-6 months enrolled; 11 excluded. 8 received ketorolac, 6 placebo | Posted | Median | Full Range | percentage of time in 12 h after drug | 12 hours after ketorolac or placebo infusion |
|
|
|
| Primary | Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants | stereo-specific ketorolac clearance by population-based analysis (NONMEM) | 52 infants aged 6-18 months enrolled; 15 excluded for abnormal laboratory results or intravenous sampling catheters that did not allow sampling. 25 infants aged 6-18 months received ketorolac, 12 received placebo. Doses of 0.5 or 1 mg/kg reported together since no difference found in handling. | Posted | Mean | Standard Error | ml/min | 24 hours after surgery |
|
|
|
| Primary | Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants | population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery | of 52 enrolled infants aged 6-18 months, 37 completed the study. Of these, 25 received drug, 12 placebo.Doses of 0.5 or 1 mg/kg showed no difference in handling so reported together. | Posted | Mean | Standard Error | ml | 24 hours after surgery |
|
|
|
| Primary | Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants | population-based analysis of ketorolac stereo-isomers | 52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo. Drug handling not different at doses of 0.5 or 1 mg/kg so reported together. | Posted | Mean | Standard Error | ml | 24 hours after surgery |
|
|
|
| Primary | Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery | noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants | 52 infants of the 77 total were aged 6-18 months. 15 were excluded for abnormal laboratory values at screening or for lack of access to draw blood samples. 25 received drug, 12 placebo.Doses 0.5 or 1 mg/kg reported together since no difference in analysis. | Posted | Mean | Standard Deviation | min | 24 hours after surgery |
|
|
|
| Secondary | Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery | total amount of morphine given for 12 hours after ketorolac or placebo infusion in 6-18 month old infants after surgery | 52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac and 12 received placebo infusion after surgery | Posted | Mean | Standard Deviation | mg/kg | 24 hours after surgery |
|
|
|
| Secondary | Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants | continuous oximetry monitoring for 12 hours after ketorolac or placebo intravenous infusion in 6-18 month old infants after surgery | 52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo | Posted | Mean | Standard Deviation | per cent time of 12 hours | 24 hours after surgery |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Ketorolac 0.5 mg/kg Intravenous | intravenous infusion over 10 minutes | 0 | 11 | 0 | 11 |
| EG002 | Dextrose 5% in Water (D5W) | intravenous infusion over 10 minutes | 0 | 18 | 0 | 18 |
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| D006571 | Heterocyclic Compounds |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |