Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

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.
    

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 the package insert in patients experiencing moderate to severe pain following
           dental implant surgery. This open label study should provide data that will allow us to
           estimate sample size for a future placebo-controlled trial in the dental implant surgery
           population.

        2. Primary Outcome Variable(s) To determine if intranasal ketorolac significantly reduces
           pain intensity scores when compared to baseline pain intensity as measured by the area
           under the 6-hour pain intensity difference (SPID-6).

        3. Secondary Outcome Variable(s) To determine the median onset of first perceptible,
           confirmed first perceptible, and meaningful pain relief of intranasal ketorolac in
           dental implant surgery patients.

      To compare mean post-dose pain intensity scores at each time-point with the baseline pain
      intensity score during the initial 6-hour evaluation period.

      To calculate the area under the 6-hour pain relief time action curve (TOTPAR-6) for
      intranasal ketorolac.

      To calculate the percentage of subjects who reach a level of at least moderate pain by
      achieving a score of at least 40 mm on a 100 mm visual analog scale within 5 hours after the
      completion of surgery.

      To determine the mean number of days of analgesic dosing in dental implant surgery patients
      when employing intranasal ketorolac as their pain medication.

      To determine the number of patients taking rescue medication (acetaminophen 650 mg) and the
      mean number of rescue medication doses taken in dental implant surgery patients when
      employing intranasal ketorolac as their pain medication.

      To determine the overall tolerability of intranasal ketorolac in dental implant surgery
      patients.
    

Intervention name(s): Ketorolac Nasal Spray
Intervention type(s): Drug
Intervention description(s): 15.75 mg nasal spray delivery to each nostril no more than every six hours
Other intervention name(s): SPRIX
Intervention MeSH terms: Ketorolac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute pain; dental pain; intranasal ketorolac; dental implant surgery