15 mg vs 30 mg IV ketorolac for ED kidney stone (renal colic) pain
Evaluation of the Effects of Ketorolac 15mg IV Versus 30mg IV on Duration of Analgesia in Patients Who Present to the Emergency Department With Renal Colic
This will test whether 15 mg or 30 mg IV ketorolac gives longer pain relief for adults under 65 who come to the ED with suspected kidney stone pain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hackensack Meridian Health Academic / other |
| Locations | 1 site (Hackensack, New Jersey) |
| Trial ID | NCT05776953 on ClinicalTrials.gov |
What this trial studies
Adult emergency department patients with suspected renal colic and a pain score of 4 or greater will be prospectively treated with either 15 mg or 30 mg of IV ketorolac. Pain control will be tracked up to 120 minutes or at discharge to compare the duration of analgesia between the two doses. Key exclusions include ketorolac allergy, pregnancy, known renal insufficiency, recent analgesic use, weight under 50 kg, age over 65, or inability to read/write English or Spanish. The study is conducted at a single academic ED to capture real-world emergency care workflow.
Who should consider this trial
Good fit: Adults under 65 presenting to the Hackensack ED with suspected renal colic, pain score ≥4, weighing ≥50 kg, not pregnant, without renal insufficiency or recent analgesic use, and who read/write English or Spanish.
Not a fit: Patients over 65, pregnant individuals, those with renal insufficiency or ketorolac allergy, people under 50 kg, those who received analgesics within 4 hours, or people who cannot read/write English or Spanish are not eligible and would not benefit from this protocol.
Why it matters
Potential benefit: If successful, a lower ketorolac dose could provide adequate pain relief with fewer side effects and help streamline ED flow.
How similar studies have performed: Prior studies such as Motov et al. and Eidinejad et al. have shown ketorolac is effective for acute pain at early timepoints, but direct comparisons of 15 mg versus 30 mg for analgesic duration out to 120 minutes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients will be included if they present to the Emergency Department with (all of the following): * 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 Exclusion Criteria: Patients will be excluded if any of the following apply: * 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 * Body weight \< 50 kg * Age greater than 65 years * Patients that do no read/write Spanish or English
Where this trial is running
Hackensack, New Jersey
- Hackensack Univarsity medical Center — Hackensack, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Biren Bhatt, MD — Hackensack Meridian Health
- Study coordinator: Biren Bhatt, MD
- Email: biren.bhatt@hmhn.org
- Phone: 551-996-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.