The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ketorolac Tromethamine

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ketorolac Tromethamine (15 mg)

Ketorolac Tromethamine (30 mg)

Arm Description

Ketorolac Tromethamine - single dose (15 mg) administered intranasally (IN) for subjects weighing <50 kg.

Ketorolac Tromethamine - single dose (30 mg) administered intranasally (IN) for subjects weighing ≥50 kg.

Outcomes

Primary Outcome Measures

Cmax (the Maximum Observed Plasma Concentration)

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.

Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)

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.

AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-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.

AUCinf (the AUC Time From Zero to Infinity, Where Possible)

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).

AUC 0-24 (the AUC From Time Zero to 24 Hours Post-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.

t1/2 (the Terminal Half-life, Where Possible)

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.

MRT (Mean Residence Time)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01363076

First Posted

May 27, 2011

Last Updated

February 7, 2017

Sponsor

Egalet Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01363076

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Egalet Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketorolac Tromethamine (15 mg)

Arm Type

Experimental

Arm Description

Ketorolac Tromethamine - single dose (15 mg) administered intranasally (IN) for subjects weighing <50 kg.

Arm Title

Ketorolac Tromethamine (30 mg)

Arm Type

Experimental

Arm Description

Ketorolac Tromethamine - single dose (30 mg) administered intranasally (IN) for subjects weighing ≥50 kg.

Intervention Type

Drug

Intervention Name(s)

Ketorolac Tromethamine

Intervention Description

Single IN dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.

Intervention Type

Drug

Intervention Name(s)

Ketorolac Tromethamine

Intervention Description

Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.

Primary Outcome Measure Information:

Title

Cmax (the Maximum Observed Plasma Concentration)

Description

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.

Time Frame