Status:
COMPLETED
Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
Lead Sponsor:
Hersh, Elliot V., DMD, MS, PhD
Conditions:
Acute Pain
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
The surgical placement of dental implants is presently a common procedure performed by oral surgeons, periodontists, and general dentists. The surgery can be performed under local anesthesia and invol...
Detailed Description
OBJECTIVES 1. Overall Objectives The purpose of this pilot study will be to evaluate the analgesic efficacy and tolerability of intranasal ketorolac employed at doses and dosing intervals stated in t...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Male or female between 18 and 64 years of age.
- Must sign informed consent prior to initiation of any study procedures. The subject must be able to understand and agree to cooperate with study requirements.
- BMI between 19 and 29 kg/m2.
- Must require the surgical placement of 1 - 3 dental implants that are being placed in a one or two stage non-immediately loaded surgical procedure employing 2% lidocaine and/or 4% articaine with epinephrine and/or 3% mepivacaine plain for local anesthesia.
- Females of child-bearing potential must have a negative urine pregnancy test at screening and immediately prior to the initiation of dental implant surgery and must have been using adequate means of birth control (abstinence, oral contraceptive steroids, intrauterine device (IUD), etc.) for at least one month prior to study entry and during the study.
- In the opinion of the investigators the subject can safely tolerate ketorolac and acetaminophen.
- \-
Exclusion
- Key Exclusion Criteria
- Require the placement of more than 3 implants or require extensive bone grafting in addition to implant placement.
- Need to administer anxiolytic/sedation drugs during surgery other than nitrous oxide/oxygen.
- Need to administer the long acting local anesthetic bupivacaine with 1:200,000 epinephrine.
- Implant(s) that are going to be immediately loaded on the day of surgery
- Females that are pregnant or breast feeding
- Allergies or hypersensitivity (aspirin sensitive asthma) to ketorolac, aspirin, ibuprofen, other NSAIDs, or acetaminophen.
- History of gastrointestinal ulcers and/or bleeding.
- On warfarin, dicumarol, clopidogrel or any other anticoagulant or antiplatelet therapy other than low dose (81 mg - 325 mg) aspirin.
- Clinically significant kidney or liver disease where the intake of NSAIDs or acetaminophen would put the subject at undo risk.
- Blood pressure greater than 160/95 at the time of screening or immediately before surgery.
- Inflammation of the nasal mucosa or upper respiratory tract infection
- Have ingested any analgesic agent within 48 hours of surgery.
- \-
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01490931
Start Date
November 1 2011
End Date
August 1 2012
Last Update
May 9 2014
Active Locations (1)
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1
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States, 19104-6030