A Single Arm, Open Label Study to Compare the Pharmacokinetics, Safety, and Efficacy of SPRIX (Intranasal Ketorolac Tromethamine) in 12 to 17 Year Old Patients vs. Adult Patients (18-64 Years) Undergoing Open Surgical Procedures

This is a study of intranasal (IN) ketorolac tromethamine (SPRIX) in pediatric subjects age 12-17 years vs. adults ages 18-64 years undergoing open surgical procedures that are expected to result in at least a moderate level of pain (i.e., 40 or above on a 0-100 Visual Analog Scale (VAS) in which 0 is no pain and 100 is the worst pain imaginable). Following surgery subjects will receive their 1st dose of SPRIX, if and when pain reaches a VAS of 40 or more, followed by SPRIX administration every 6 hours. Blood samples for PK assessment will then be collected for PK assessment pre-dose, at 0.25, 0.5, 0.75, 1, 2, and 4 hours after the first dose, at 6 hours (immediately before the 2nd dose), and immediately before each of the next several subsequent q6h doses up to the dose to be administered on the morning of post-operative day 2. Blood samples will then be collected at 1, 2, 4, 6, 8, 12, and 24 hours after receiving the morning dose on day 2 (i.e., last blood sample for PK will be collected on the morning of post-operative day 3). Pain intensity (PI) will be assessed using the 0-100 VAS at 0.5, 1, 2, 4, and 6 hours post dose, at 2 hours after the 2nd dose, and then immediately prior to each dose at 12, 18, and 24 hours from baseline. Patients may elect to continue taking SPRIX for a total of 5 days with daily assessments of pain intensity using a diary. A final follow-up phone interview will be conducted 14 days after the final dose of study drug. Thus, each subject's study participation will consist of a screening visit, a treatment/assessment period of up to 5 days, and a follow-up interview.