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Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
NCT00266786 · View on ClinicalTrials.gov ↗
Study Summary
Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
Conditions Studied
Interventions
- DRUG Intranasal Placebo
- DRUG Intranasal Ketorolac Tromethamine
Study Locations (6)
California
- Methodist Hospital — Arcadia
- Glendale Adventist Medical Center — Glendale
- Clinical Management Services, Inc. — Pasadena
Texas
- Memorial Hermann Healthcare System — Houston
- Houston Perinatal Associates — Houston
Other
- Waikato Clinical Research — Hamilton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2005-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00266786
The ClinicalTrials.gov registry entry for NCT00266786 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 321 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Egalet, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions — of which Intranasal Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00266786 reports 6 study locations spanning 3 distinct geographic areas — top geographies include California, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00266786 about?
NCT00266786 is a clinical study titled "Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery". Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety...
What is the current status of trial NCT00266786?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 321 participants. The study started on 2005-12.
What conditions does trial NCT00266786 study?
This clinical trial studies the following conditions: Postoperative Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00266786?
The interventions under investigation include: Intranasal Placebo (DRUG), Intranasal Ketorolac Tromethamine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00266786?
This trial is sponsored by Egalet, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00266786 being conducted?
This trial has 6 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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