Gregory Hammer
Study of blood levels of Ketorolac Administered Intranasally to Children for pain after surgery
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose is to evaluate the pharmacokinetics (the study of absorption and metabolism) of ketorolac, a pain medication, when given as a nasal spray to pediatric postoperative patients.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Ketolorac
Phase:
Phase 1Eligibility
Ages Eligible for Study:
12 years to 16 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Inclusion: children aged 12 to 17 years; body weight >30 kg and <100 kg; negative serum or urine pregnancy test; 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 post-treatment visit.
Key Exclusion Criteria:
allergy or sensitivity to ketorolac or EDTA; allergic reaction to aspirin or other NSAIDs; current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events (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 mucosal damage; history of peptic ulcer disease or gastrointestinal bleeding; advanced renal impairment or a risk for renal failure due to volume depletion; 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; pregnancy or breastfeeding; previous participation in this study; underwent head, neck, oral, or nasal surgery.
Additional Study Details
Official Title:
A Study of the Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain in Children Aged 12 through 17 YearsAnticipated start date:
6/20/2007Lead Sponsor:
Roxro Pharama, Inc.Investigator(s):
- Gregory Hammer
- David R. Drover
- Hong Cao
- Carol A. Cohane
- Ava M. Eagle
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
PharmacokineticsPrimary Outcomes:
- PK
Secondary Outcomes:
- safety
Total Number to be Enrolled:
20Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- IRB#8169
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
4/10/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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