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NCT01260883 · ClinicalTrials.gov registry record · Phase 3
Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
A Phase 3 study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT01260883: Completed Phase 3 study, sponsored by Seattle Children's Hospital.
NCT01260883 is a Phase 3 study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 77 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01260883, a Phase 3 study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
Study 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.
Primary Outcome
stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM)
Interventions
- DRUG Placebo
- DRUG Ketorolac Tromethamine 1 mg/kg
- DRUG Ketorolac Tromethamine 0.5 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2000-05 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT01260883 record still lists
NCT01260883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01260883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01260883 about?
NCT01260883 is a clinical study titled "Ketorolac in Postoperative Infants: Pharmacokinetics and Safety". 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 ...
What is the current status of trial NCT01260883?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2000-05. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01260883?
The interventions under investigation include: Placebo (DRUG), Ketorolac Tromethamine 1 mg/kg (DRUG), Ketorolac Tromethamine 0.5 mg/kg (DRUG).
Who is sponsoring clinical trial NCT01260883?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01260883's enrollment target sits among peer trials
77 1771st of 2000 higher than 228 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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