An Early Phase 1 interventional study of Ketorolac in Pain and Renal Colic, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Tehran University of Medical Sciences · Early Phase 1, Interventional, and Treatment
Hypothesis: Intravenous administration of Ketorolac 10 mg and 20 mg is as effective as 30 mg in treating renal colic pain in patients presenting to the emergency department
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED). Because of the Ketorolac significant analgesic potency, it is usually used for moderate-to-severe pain. However, ketorolac has several side effects, of which gastrointestinal hemorrhage is most concerning. "Analgesic ceiling" is defined as the dose beyond which no additional analgesia can be achieved and on the other hand, more side effects might be encountered. Several studies suggested 10 mg as analgesic ceiling. Despite this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).
148 studies on the registry are indexed under Colic; 21 are open to participants now.
This study's enrollment of 165 is above the median of 88 across 122 interventional studies indexed under Colic.
Browse Colic studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be administered 10 mg of Ketorolac.
Drug: Ketorolac
Subjects will be administered 20 mg of Ketorolac
Drug: Ketorolac
As a part of standard care, subjects will be administered 30 mg of Ketorolac.
Drug: Ketorolac
Subject will receive 10, 20, and 30mg of Ketorolac.
Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Time frame: 30 Minutes
Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Time frame: 15 Minutes
Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Time frame: 45 Minutes
Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Time frame: 60 Minutes
Adverse Effects
Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)
Time frame: 60 Minutes
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences