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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.

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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

FieldValue
Enrollment Target 77 participants
Start Date 2000-05
Est. Completion 2010-12
Phase Phase 3

Sponsor

Seattle Children's Hospital

168 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.