Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain
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|ClinicalTrials.gov Identifier: NCT01351090|
Recruitment Status : Completed
First Posted : May 10, 2011
Results First Posted : October 18, 2012
Last Update Posted : October 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Ketorolac tromethamine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2, Double-blind, Randomized Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain|
|Actual Study Completion Date :||October 2007|
|Experimental: Ketorolac tromethamine (5%)||
Drug: Ketorolac tromethamine
10 mg Intranasal (2 x 100 uL of a 5% solution)
|Experimental: Ketorolac tromethamine (15%)||
Drug: Ketorolac tromethamine
30 mg Intranasal (2 x 100 uL of a 15% solution)
|Placebo Comparator: Placebo||
- 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 [ Time Frame: 6 hours after study 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. 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351090
|Waikato Clinical Research|
|Hamilton, New Zealand|
|Study Chair:||Lincoln Bynum, MD||ICON Development Solutions|