Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Ketorolac Nasal Spray
Intervention description: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: acute pain; dental pain; intranasal ketorolac; dental implant surgery

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 involves the incision of soft tissue to expose the underlying bone,
      preparation of the implant site using a specialized surgical drill, and.screwing the implant
      into bone using a specialized headpiece. Dental implant patients experience postoperative
      pain yet there are no studies in the literature which have evaluated the efficacy of
      analgesics in this patient population. The current pilot study will evaluate the analgesic
      effects and tolerability of a recently FDA-approved analgesic formulation of intranasal
      ketorolac (SPRIX®) in 25 patients who have 1 - 3 dental implants surgically placed. Patients
      will self administer the ketorolac nasal spray (one spray in each nostril, 31.5 mg total
      dose) when their postoperative pain reaches at least a moderate severity. Pain intensity and
      pain relief scores will then be recorded every 20 minutes for the first hour, at 1.5 and 2
      hours and then hourly through 6 hours on a validated analgesic diary. Side effects will be
      recorded when and if they occur. Patients will then transition to a multi-dose phase where
      they will be allowed to dose with ketorolac as indicated in the package insert (up to 4 times
      per day for 5 days). Patients will record the time of each dose, a daily assessment of
      overall efficacy and side effects, and the use of any rescue medication (acetaminophen 650
      mg) on a take home diary.
    

Eligibility criteria:

        Inclusion Criteria:

        Key Inclusion Criteria

          1. Male or female between 18 and 64 years of age.

          2. 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.

          3. BMI between 19 and 29 kg/m2.

          4. 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.

          5. 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.

          6. In the opinion of the investigators the subject can safely tolerate ketorolac and
             acetaminophen.

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        Exclusion Criteria:

        Key Exclusion Criteria

          1. Require the placement of more than 3 implants or require extensive bone grafting in
             addition to implant placement.

          2. Need to administer anxiolytic/sedation drugs during surgery other than nitrous
             oxide/oxygen.

          3. Need to administer the long acting local anesthetic bupivacaine with 1:200,000
             epinephrine.

          4. Implant(s) that are going to be immediately loaded on the day of surgery

          5. Females that are pregnant or breast feeding

          6. Allergies or hypersensitivity (aspirin sensitive asthma) to ketorolac, aspirin,
             ibuprofen, other NSAIDs, or acetaminophen.

          7. History of gastrointestinal ulcers and/or bleeding.

          8. On warfarin, dicumarol, clopidogrel or any other anticoagulant or antiplatelet therapy
             other than low dose (81 mg - 325 mg) aspirin.

          9. Clinically significant kidney or liver disease where the intake of NSAIDs or
             acetaminophen would put the subject at undo risk.

         10. Blood pressure greater than 160/95 at the time of screening or immediately before
             surgery.

         11. Inflammation of the nasal mucosa or upper respiratory tract infection

         12. Have ingested any analgesic agent within 48 hours of surgery.

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