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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 is a Phase 3 study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 77 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01260883
The ClinicalTrials.gov registry entry for NCT01260883 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01260883 reports 0 study locations.
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.
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