This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA). The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN) doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
127
10 mg Intranasal (2 x 100 uL of a 5% solution)
30 mg Intranasal (2 x 100 uL of a 15% solution)
Intranasal
Waikato Clinical Research
Hamilton, New Zealand
Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours
Time frame: 8-hour intervals from the start of dosing through 24 hours
Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours
Time frame: 8-hour intervals from the start of dosing through 48 hours
Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours
Time frame: 8-hour intervals from 24 hours after the start of dosing through 48 hours
Pain Intensity Difference (PID) Scores
Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.
Time frame: 6 hours after study drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.