Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00266786 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
A Phase 3 study of Postoperative Pain, sponsored by Egalet.
- Completed
- Registry status
- Phase 3
- Development phase
- 321
- Enrollment target
- 6
- Study locations
NCT00266786: Completed Phase 3 study of Postoperative Pain, sponsored by Egalet.
NCT00266786 is a Phase 3 study of Postoperative Pain that has completed, run by Egalet. The registered enrollment target is 321 participants, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (40% higher). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00266786, a Phase 3 study of Postoperative Pain, has completed, sponsored by Egalet.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 321 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained every hour following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at
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 |
What the finished NCT00266786 record still lists
NCT00266786 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (40% higher).
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.
NCT00266786 lists 6 locations in 3 states (California, Texas, Other).
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.
What interventions are being tested in trial NCT00266786?
The interventions under investigation include: Intranasal Placebo (DRUG), Intranasal Ketorolac Tromethamine (DRUG).
Who is sponsoring clinical trial NCT00266786?
This trial is sponsored by Egalet, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00266786's enrollment target sits among peer trials
321 18th of 120 higher than 103 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain 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
-
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
RECRUITING · Phase 3
-
A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
RECRUITING · Phase 3
-
RADA16 for Adult Tonsillectomy
RECRUITING · Phase 3
-
Methadone in TKA for Post-op Pain and Opioid Reduction
RECRUITING · Phase 3
-
Methadone in THA for Post-op Pain and Opioid Reduction
RECRUITING · Phase 3
-
Perioperative Lidocaine and Ketamine in Abdominal Surgery
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03715933 · 321 participants · Phase 1
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
- NCT05922878 · 321 participants · Phase 2
Study of ALTO-300 in MDD
- NCT04090359 · 322 participants · Phase 4
Dual Mobility Acetabular Cups in Revision TJA
- NCT04924075 · 322 participants · Phase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia