- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01363076
The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
A Study of the Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
This was an open-label PK study in pediatric subjects who had undergone general surgery. Each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (IN) tromethamine, and a follow-up visit.
Following surgery, subjects received IN ketorolac 15 mg (weight < 50 kg) or 30 mg (weight > or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the subjects had access to an opioid analgesic administered by patient-controlled analgesia (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points following the dose of ketorolac.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children aged 12 through 17 years
- Body weight > or = 30 kg and < or = 100 kg
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test result prior to entry into the study
- A legal representative able to provide written informed consent
- Willing and able to comply with all testing and requirements defined in the protocol
- Willing and able to complete the posttreatment visit
Exclusion Criteria:
- Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
- Allergic reaction to aspirin or other NSAIDs
- Had an upper respiratory tract infection or other respiratory tract condition (eg, active allergic rhinitis) that could interfere with the absorption of the nasal spray or with the assessment of AEs
- Use of any IN product within 24 hours prior to study entry
- Clinically significant abnormality on screening laboratory tests
- History of cocaine use resulting in nasal mucosal damage
- History of peptic ulcer disease or gastrointestinal bleeding
- Had advanced renal impairment or a risk for renal failure due to volume depletion
- A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation
- Participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study
- Allergy or significant reaction to opioids
- Was pregnant or breastfeeding
- Previously participated in this study
- The surgical procedure involved head, neck, oral, or nasal surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ketorolac Tromethamine (15 mg)
Ketorolac Tromethamine - single dose (15 mg) administered intranasally (IN) for subjects weighing <50 kg.
|
Single IN dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
|
EXPERIMENTAL: Ketorolac Tromethamine (30 mg)
Ketorolac Tromethamine - single dose (30 mg) administered intranasally (IN) for subjects weighing ≥50 kg.
|
Single IN dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax (the Maximum Observed Plasma Concentration)
Time Frame: 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.
|
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
|
Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)
Time Frame: 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.
|
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
|
AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose)
Time Frame: 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.
|
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
|
AUCinf (the AUC Time From Zero to Infinity, Where Possible)
Time Frame: 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).
|
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
|
AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose
Time Frame: 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.
|
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
|
t1/2 (the Terminal Half-life, Where Possible)
Time Frame: 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.
|
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
|
MRT (Mean Residence Time)
Time Frame: 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.
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lincoln Bynum, MD, ICON Developmental Solutions
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketorolac
- Ketorolac Tromethamine
Other Study ID Numbers
- ROX 2006-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on Ketorolac Tromethamine
-
Oman Medical Speciality BoardCompletedAcute Renal ColicOman
-
Darnitsa Pharmaceutical CompanyCompleted
-
William Beaumont Army Medical CenterCompletedMusculoskeletal Pain | Analgesia | Adverse EventUnited States
-
Queen's UniversityCompleted
-
Seattle Children's HospitalUniversity of WashingtonCompletedPostoperative Pain in InfantsUnited States
-
Université Catholique de LouvainAnticancer Fund, BelgiumCompletedCurative Breast Cancer Surgery | Inflammatory Positive/Negative Status | Pre Surgical Incision AdministrationBelgium
-
Beth Israel Deaconess Medical CenterSociety for Obstetric Anesthesia and PerinatologyActive, not recruitingPostoperative Pain | Postpartum Hemorrhage | Blood Loss, Postoperative | Analgesia, Obstetrical | Coagulation Defect; Postpartum | Nonsteroidals (NSAIDs)Toxicity | Ketorolac Adverse ReactionUnited States
-
New Mexico Cancer Care AllianceCompletedOvarian Cancer | Fallopian Tube Cancer | Peritoneal Cavity CancerUnited States
-
Egalet LtdCompleted
-
Egalet LtdCompleted