A Phase 3 interventional study of Ketorolac tromethamine and Placebo in Postoperative Pain, sponsored by Egalet Ltd. Completed at 1 site in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-08.
Sponsored by Egalet Ltd · Phase 3, Interventional, and Treatment
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 300 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Drug: Ketorolac tromethamine
Drug: Placebo
30 mg intranasal post-surgery for up to 5 days total
Intranasal post-surgery for up to 5 days total
The Summed Pain Intensity Difference (SPID) on Day 1
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.
Time frame: 6 hours after drug administration
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.
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.
Time frame: Hourly following the first dose of study medication up to 8 hours
Quality of analgesia
Quality of analgesia was assessed on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.
Time frame: First dose of study medication on Day 1 to the first dose of MS by PCA
Global assessment of pain control
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.
Time frame: 8 hours following first dose of study medication
Onset and duration of pain relief
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.
Time frame: 8 hours following first dose of study medication
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketorolac Tromethamine
Egalet Ltd