Evaluation of the Effects of Ketorolac Dose on Duration of Analgesia in Emergency Department (ED) Renal Colic Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHackensack Meridian Health
About this trial
This is a prospective interventional study examining the effect of ketorolac at doses of 15mg versus 30 mg for duration of analgesia in emergency department patients with suspected renal colic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult emergency department patients < 65 years old
One or more of the following common ED chief complaints associated with the suspected diagnosis of renal colic. These chief complaints include but are not limited to: flank pain, back pain, abdominal pain, left and/or right lower quadrant pain, and/or pelvic pain
Pain score of 4 or greater on the 0-10 NRS
Determination of treatment with IV ketorolac
Disqualifiers
Allergy to ketorolac
Pregnant patients
Previously received analgesic medications within 4 hours prior to administration of ketorolac in our ED
Known or stated history of renal insufficiency
Trial design
Design model
Parallel
Treatments tested in this trial
Ketorolac
DrugIV Ketorolac for pain
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: 15mg IV KetorolacActive comparator 1 intervention
Group B: 30mg IV KetorolacActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain scale post ketorolac administration
This study may prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction of 15 mg versus 30 mg of intravenous (IV) ketorolac at 120 minutes after administration to treat renal colic in the emergency department. The scale ranges from 0 to 10 with 0 being "no pain" and 10 being "very much pain".
Time frame
At 120 minutes (+/-10 minutes) from medication administrationSecondary outcomes
1
Change in pain scale post ketorolac administration at different time points
This study may also determine the mean NRS pain score reduction at different time points (90 minutes, 150 minutes, and 180 minutes) after IV ketorolac administration. The scale ranges from 0 to 10 with 0 being "no pain" and 10 being "very much pain".
Time frame
At 90 minutes (+/-10 minutes) from medication administration2
Change in pain scale post ketorolac administration at different time points
This study may also determine the mean NRS pain score reduction at different time points (90 minutes, 150 minutes, and 180 minutes) after IV ketorolac administration. The scale ranges from 0 to 10 with 0 being "no pain" and 10 being "very much pain".
Time frame
At 150 minutes (+/-10 minutes) from medication administration3
Change in pain scale post ketorolac administration at different time points
This study may also determine the mean NRS pain score reduction at different time points (90 minutes, 150 minutes, and 180 minutes) after IV ketorolac administration. The scale ranges from 0 to 10 with 0 being "no pain" and 10 being "very much pain".
Time frame
At 180 minutes (+/-10 minutes) from medication administration4
Need for additional rescue analgesia
Study may also examine the number of patients requesting rescue analgesia within two hours of ketorolac administration (yes vs. no)
Time frame
At 120 minutes from medication administrationSponsors and contacts
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Source ClinicalTrials.gov