Postoperative Pain in Infants Clinical Trial
Official title:
Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
| Verified date | June 2013 |
| Source | Seattle Children's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 77 |
| Est. completion date | December 2010 |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Months to 18 Months |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Seattle Children's Hospital | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Seattle Children's Hospital | University of Washington |
United States,
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. — View 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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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) | 24 hours following surgery | No |
| 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 | 24 hours after surgery | No |
| 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) | 24 hours post surgery | No |
| 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 | 24 hours after surgery | No |
| Primary | 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 | No |
| 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 | 24 hours after surgery | No |
| Primary | Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants | population-based analysis of ketorolac stereo-isomers | 24 hours after surgery | No |
| 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 | 24 hours after surgery | No |
| 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 | first day after surgery | No |
| 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 | 12 hours after ketorolac or placebo infusion | Yes |
| 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 | 24 hours after surgery | No |
| 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 | 24 hours after surgery | Yes |