Trial · NCT01363076
The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
NCT01363076, Phase 1, Completed, Egalet Ltd; results first posted 2012-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years. Trials, record NCT01363076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01363076
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
- NCT number
- NCT01363076
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Egalet Ltd
- Conditions
- Postoperative Pain
- Interventions
- Ketorolac Tromethamine, Ketorolac Tromethamine
- First posted
- 2011-06-01
- Last updated
- 2017-03-16
- Results first posted
- 2012-04-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax (the Maximum Observed Plasma Concentration) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. |
| Primary | Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. Individual plasma ketorolac concentrations were summarized by dose level for the PK population at each sampling time using n, arithmetic mean, SD, CV(%), geometric mean, 95% confidence intervals (CI) for the arithmetic mean, median, minimum, and maximum. |
| Primary | AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. |
| Primary | AUCinf (the AUC Time From Zero to Infinity, Where Possible) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. AUCinf calculated as: AUCinf = AUC(0-24) + (concentration at 24 hr/elimination constant). |
| Primary | AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. |
| Primary | t1/2 (the Terminal Half-life, Where Possible) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. |
| Primary | MRT (Mean Residence Time) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax (the Maximum Observed Plasma Concentration) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | ng/mL | MEAN | |
| PRIMARY | Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | hr | MEDIAN | |
| PRIMARY | AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | ng•h/mL | MEAN | |
| PRIMARY | AUCinf (the AUC Time From Zero to Infinity, Where Possible) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | ng•h/mL | MEAN | |
| PRIMARY | AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | ng•h/mL | MEAN | |
| PRIMARY | t1/2 (the Terminal Half-life, Where Possible) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | hr | MEAN | |
| PRIMARY | MRT (Mean Residence Time) | All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose | hr | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax (the Maximum Observed Plasma Concentration) | Ketorolac Tromethamine (15 mg) | 1153.9 | Standard Deviation 485.0 | ng/mL | |
| Cmax (the Maximum Observed Plasma Concentration) | Ketorolac Tromethamine (30 mg) | 1625.3 | Standard Deviation 538.5 | ng/mL | |
| Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured) | Ketorolac Tromethamine (15 mg) | 0.720 | Full Range 0.38 to 6.07 | hr | |
| Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured) | Ketorolac Tromethamine (30 mg) | 0.780 | Full Range 0.48 to 5.00 | hr | |
| AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose) | Ketorolac Tromethamine (15 mg) | 9308.2 | Standard Deviation 6214.2 | ng•h/mL | |
| AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose) | Ketorolac Tromethamine (30 mg) | 10662.1 | Standard Deviation 5383.5 | ng•h/mL | |
| AUCinf (the AUC Time From Zero to Infinity, Where Possible) | Ketorolac Tromethamine (15 mg) | 10590.7 | Standard Deviation 7818.4 | ng•h/mL | |
| AUCinf (the AUC Time From Zero to Infinity, Where Possible) | Ketorolac Tromethamine (30 mg) | 11949.5 | Standard Deviation 6506.1 | ng•h/mL | |
| AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose | Ketorolac Tromethamine (15 mg) | 9600.5 | Standard Deviation 5959.9 | ng•h/mL | |
| AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose | Ketorolac Tromethamine (30 mg) | 11317.2 | Standard Deviation 5666.1 | ng•h/mL |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketorolac Tromethamine (15 mg) | 7 | |
| Overall Study | STARTED | Ketorolac Tromethamine (30 mg) | 13 | |
| Overall Study | COMPLETED | Ketorolac Tromethamine (15 mg) | 7 | |
| Overall Study | COMPLETED | Ketorolac Tromethamine (30 mg) | 12 | |
| Overall Study | NOT COMPLETED | Ketorolac Tromethamine (15 mg) | 0 | |
| Overall Study | NOT COMPLETED | Ketorolac Tromethamine (30 mg) | 1 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Ketorolac Tromethamine (15 mg) | 1 | 7 | 1 |
| other | Nausea | Gastrointestinal disorders | Ketorolac Tromethamine (30 mg) | 1 | 13 | 1 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Ketorolac Tromethamine (15 mg) | 2 | 7 | 2 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Ketorolac Tromethamine (30 mg) | 1 | 13 | 1 |
| other | Dysgeusia | Nervous system disorders | Ketorolac Tromethamine (15 mg) | 0 | 7 | 0 |
| other | Dysgeusia | Nervous system disorders | Ketorolac Tromethamine (30 mg) | 1 | 13 | 1 |
| other | Vomiting | Gastrointestinal disorders | Ketorolac Tromethamine (15 mg) | 0 | 7 | 0 |
| other | Vomiting | Gastrointestinal disorders | Ketorolac Tromethamine (30 mg) | 2 | 13 | 2 |
| other | Rhinalgia | Respiratory, thoracic and mediastinal disorders | Ketorolac Tromethamine (15 mg) | 0 | 7 | 0 |
| other | Rhinalgia | Respiratory, thoracic and mediastinal disorders | Ketorolac Tromethamine (30 mg) | 1 | 13 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketorolac Tromethamine (15 mg) | ||
| Total, all-cause mortality | Ketorolac Tromethamine (30 mg) | ||
| Total, other adverse events | Ketorolac Tromethamine (15 mg) | 3 | 7 |
| Total, other adverse events | Ketorolac Tromethamine (30 mg) | 8 | 13 |
| Total, serious adverse events | Ketorolac Tromethamine (15 mg) | 0 | 7 |
| Total, serious adverse events | Ketorolac Tromethamine (30 mg) | 1 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ketorolac Tromethamine (15 mg) vs Ketorolac Tromethamine (30 mg): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01363076
GET https://conductscience.org/api/trials/v1/NCT01363076/registered