Clinical trial NCT01363076: The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
Official title: A Study of the Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Pain
Lead sponsor: Egalet Ltd
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cmax (the Maximum Observed Plasma Concentration)
timeFrame: 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
measure: Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)
timeFrame: 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
measure: AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose)
timeFrame: 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
measure: AUCinf (the AUC Time From Zero to Infinity, Where Possible)
timeFrame: 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
measure: AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose
timeFrame: 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
measure: t1/2 (the Terminal Half-life, Where Possible)
timeFrame: 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
measure: MRT (Mean Residence Time)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: ICON Developmental Solutions
name: Lincoln Bynum, MD
role: STUDY_CHAIR
References: