Safety and Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
|ClinicalTrials.gov Identifier: NCT01347853|
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : February 8, 2017
This was a randomized, double-blind, placebo-controlled study in subjects who underwent major surgery. Each subject's study participation consisted of a screening visit and a treatment period of up to 5 days. Following surgery (Day 0), subjects were randomly assigned to receive intranasal ketorolac 30 mg or intranasal placebo when the pain intensity (PI) rating equaled at least 40 mm on a 100-mm visual analog scale (VAS). Subjects received study drug every 8 hours for 48 hours and then 3 times daily for up to 5 calendar days in total; the frequency of dosing could be reduced after 48 hours. Starting at the time of the first dose of study drug and continuing for the first 48 hours after surgery, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA). After PCA was no longer required, backup pain relief was provided by another standard nonsteroidal anti-inflammatory drug (non-NSAID) analgesic regimen. If the subjects were discharged before postoperative Day 4, they could self-medicate at home through postoperative Day 4. A safety follow-up evaluation was conducted by telephone approximately 14 days after the end of dosing in a subset of subjects (n = 60).
The primary objective was to evaluate the analgesic efficacy of multiple intranasal doses of ketorolac administered for up to 5 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 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2007|
|Experimental: Ketorolac tromethamine||
Drug: Ketorolac tromethamine
30 mg intranasal post-surgery for up to 5 days total
|Placebo Comparator: Placebo||
Intranasal post-surgery for up to 5 days total
- 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.
- Morphine sulfate consumption at 24 hours and 48 hours [ Time Frame: 24 hours and 48 hours after drug administration ]
- Hourly Pain Intensity Difference (PID) scores. [ Time Frame: Hourly following the first dose of study medication up to 8 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. The PI values were obtained during the first 8 hours following the first dose of study medication on Day 1. 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: First dose of study medication on Day 1 to the first dose of MS by PCA ]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.
- Onset and duration of pain relief [ Time Frame: 8 hours following first dose of study medication ]The onset of pain relief was defined as the time when the stopwatch was stopped to indicate "meaningful" pain relief. Peak PID was calculated. Duration of analgesia was defined as the time from the first dose of study medication on Day 1 to the first dose of MS by PCA.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347853
|Waikato Clinical Research|
|Hamilton, New Zealand|