Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Ketorolac has been marketed for several years in other forms (tablet and injectable) for the
short-term relief of pain. This study will test whether a new dosage form (nasal spray)
containing ketorolac is effective at relieving the pain of major abdominal surgery, and will
also assess product safety. Previous studies with the nasal spray have suggested that it is
similar to the previously approved injectable form in effectiveness for pain relief and in
its safety profile.
Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when
the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first
dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to
4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug,
subjects will be given morphine sulfate or other standard analgesics. Follow-up safety
evaluations will occur about 1 and 2 weeks after the start of dosing.
Subjects will be asked to answer questions about their pain relief and any possible side
effects of the drug during the study, and will be given physical examinations, including
nasal evaluations, before and during the clinical trial. A small amount of blood will be
drawn for routine clinical laboratory testing.