Phase 3
Completed N=51
Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Postoperative Pain in Infants
Source: ClinicalTrials.gov NCT01260883 ↗
Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery — 30.7; 6.5 ml/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery |
30.7; 6.5 | — |
| PRIMARY Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants |
1480; 992 | — |
| PRIMARY Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants |
341; 658 | — |
| PRIMARY Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants |
67; 197 | — |
| PRIMARY Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants |
45.3; 7.52 | — |
| PRIMARY Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants |
2320; 1200 | — |
| PRIMARY Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants |
224; 828 | — |
| PRIMARY Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery |
50.1; 238 | — |
| SECONDARY Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery |
0.12; 0.08 | — |
| SECONDARY Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants |
NA; NA | — |
| SECONDARY Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery |
1.8; 2.2 | — |
| SECONDARY Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants |
0.8; 1 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01260883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.