Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
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.
|Postoperative Pain||Drug: Intranasal Ketorolac Tromethamine Drug: Intranasal Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
|Official Title:||A Phase 3, Double-Blind, Randomized Study of the Safety, Tolerability, and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain Following Major Abdominal Surgery|
- The Summed Pain Intensity Difference (SPID) on Day 1 [ Time Frame: 6 hours after drug administration ]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. The PI values were obtained every hour following the first dose of study medication on Day 1. Pain intensity difference (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. A summed PID (SPID) on the first postoperative day was calculated at 6 hours.
- Pain intensity difference scores [ Time Frame: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours ]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.
- Quality of analgesia [ Time Frame: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours ]Quality of analgesia was assessed on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.
- Global assessment of pain control [ Time Frame: 8 hours following first dose of study medication ]A global evaluation of pain control was conducted once daily at bedtime using a 5-point categorical scale on which 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.
- Morphine sulfate consumption at 24, 48, and 72 hours [ Time Frame: 24, 48, and 72 hours after drug administration ]
|Study Start Date:||December 2005|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
|Experimental: Intranasal Ketorolac Tromethamine||
Drug: Intranasal Ketorolac Tromethamine
Intranasal at 30mg
|Placebo Comparator: Intranasal Placebo||
Drug: Intranasal Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266786
|United States, California|
|Arcadia, California, United States, 91007|
|Glendale Adventist Medical Center|
|Glendale, California, United States, 91206|
|Clinical Management Services, Inc.|
|Pasadena, California, United States, 91105|
|United States, Texas|
|Memorial Hermann Healthcare System|
|Houston, Texas, United States, 77024|
|Houston Perinatal Associates|
|Houston, Texas, United States, 77054|
|Waikato Clinical Research|
|Hamilton, New Zealand|
|Study Chair:||Lincoln Bynum, MD||ICON Clinical Research|