Podcast: Play in new window | Download

Subscribe: RSS

Date: January 13, 2023

Reference: Razi et al. Dexamethasone and ketorolac compare with ketorolac alone in acute renal colic: A randomized clinical trial. AJEM 2022

Dr. Kevan Sternberg

Guest Skeptic: Dr. Kevan Sternberg is a urologist/endourologist. His focus is on the medical and surgical management of kidney stone disease. Dr. Sternberg did his medical school and residency training at the University of Buffalo (SUNY) and endourology fellowship at the University of Pittsburgh Medical Center.

Kevan was on the SGEM Xtra episode three years ago that brought together Emergency Medicine, Radiologists and Urologists to discuss ultrasound vs CT scans for suspected renal colic. You can listen to the SGEM podcast to hear what he thinks the impact of this initiative has been.

Case: A 38-year-old female presents to the emergency department (ED) with a five-hour history of acute onset left flank pain.  The pain comes in waves, radiates into her left groin and is associated with nausea and vomiting.  She noticed darkening of her urine, but does not have dysuria, fever, or vaginal discharge.

Background: We have looked at many different therapies to treat renal colic on the SGEM. That has included things like fluid bolus or diuretics (SGEM#32), tamsulosin (SGEM#4, #71, #154, #230), acupuncture (SGEM#220) and lidocaine (SGEM#202).

The SGEM bottom line to these different treatment options:

  • You don’t need to push fluids (oral/IV) or use diuretics to pass kidney stones.
  • Medical expulsive therapy with tamsulosin is unnecessary for stones < 5mm.
  • If a benefit does exist for Tamsulosin it’s with distal ureteral stones > 5 mm.
  • Acupuncture is not superior to morphine for renal colic.
  • The evidence doesn’t support the use of lidocaine for renal colic.

Glucocorticoids (steroids) act as anti-inflammatories, immunosuppressants, antiproliferative drugs, and have vasoconstrictive effects. It has been hypothesized that adding a long-acting glucocorticoid like dexamethasone may help with pain and vomiting associated with passing a kidney stone and decrease opioid use.

Clinical Question: Should we be adding a dexamethasone to NSAIDs for the management of suspected acute renal colic?

Reference: Razi et al. Dexamethasone and ketorolac compare with ketorolac alone in acute renal colic: A randomized clinical trial. AJEM 2022

  • Population: Patients presenting to the ED with flank pain and presumed renal colic
    • Exclusions: Pregnancy (confirmed or possible), analgesic therapy during six hours before admitted to the emergency unit, near history of hemorrhagic diathesis, addiction or recent methadone use, use of warfarin and other anticoagulants, acute abdomen, fever, BP ≥ 180/100 mmHg; any contra- indication for ketorolac including hypersensitivity to aspirin or other NSAIDs, active or history of peptic ulcer disease, a recent history of GI bleeding or perforation or suspected or confirmed cerebrovascular bleeding, advanced hepatic or renal disease, patients at risk for renal failure, hyperkalemia, and uncontrolled severe heart failure; and any contraindications for the use of dexamethasone
  • Intervention: Ketorolac 30mg IV plus dexamethasone 8mg IV
  • Comparison: Ketorolac 30mg IV
  • Outcome:
    • Primary Outcome: Change in pain on a 10-cm visual analog scale (VAS) at 30 minutes and 60 minutes
    • Secondary Outcomes: Grade of vomiting and the need for antiemetics and need for opioids
  • Type of Trial: Single-centered, triple-blind, randomized clinical trial from Iran

Authors’ Conclusions: “In comparison with the patients who just received ketorolac, adding dexamethasone provided improved pain control after 30 min of therapy”.

Quality Checklist for Randomized Clinical Trials:

  1. The study population included or focused on those in the emergency department. Yes
  2. The patients were adequately randomized. Yes
  3. The randomization process was concealed. Yes
  4. The patients were analyzed in the groups to which they were randomized. Yes
  5. The study patients were recruited consecutively (i.e. no selection bias). Yes
  6. The patients in both groups were similar with respect to prognostic factors. Yes
  7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Unsure
  8. All groups were treated equally except for the intervention. Unsure
  9. Follow-up was complete (i.e. at least 80% for both groups). Yes
  10. All patient-important outcomes were considered. No
  11. The treatment effect was large enough and precise enough to be clinically significant. No
  12. Financial conflicts of interest. No

Results: They recruited 120 participants (60 in each group), the mean age was 37.6 years of age, 70% were male and 42% reported some vomiting.

Key Result: Dexamethasone plus ketorolac was statistically superior to ketorolac alone for pain control at 30 minutes but not at 60 minutes in adults with suspected acute renal colic.

  • Primary Outcome: Change in pain from baseline using VAS
    • 30 Minutes: -5 intervention vs -3 control, p=0.014
    • 60 Minutes: -7 intervention vs -5 control, p=0.07
  • Secondary Outcomes: 
    • Grade of Vomiting: No statistical difference
    • Need for Antiemetic: 12% vs 28%, p=0.02
    • Need for Opioids: 35% vs 58%, p=0.01

  1. Did they Even Have Stones? The diagnosis was based upon cell blood count, urinary assay, US, or CT scan. I would need a CT diagnosis or an US with hydronephrosis correlated clinical to know whether these are actual stone related events. Did everyone get imaging? What was the incidence of hydronephrosis? How big were these stones? Where were these stones (proximal, mid or near the ureterovesical junction)? Flank pain can have many reasons and while the goal of this study is to address the pain, it may not be accurate to title the study using acute renal colic.
  2. Two Primary Outcomes? We know that there can be only one primary outcome. Why did they have two primary outcomes at 30 and 60 minutes?  Why would the results change after another 30 minutes? Is this clinically relevant anyway?
  3. Visual Analog Scale? Is the VAS score the most appropriate primary outcome clinically? It is a subjective outcome measure. A potentially and more important outcomes may be to see those who needed intervention due to poorly controlled pain or those who need opioids for the same.
  4. Secondary Outcome? In the trial registry they only had one secondary outcome (grade of vomiting). The publication had an additional two (need for antiemetic and need for opioids). It is unclear when these were added and if they were done post-hoc. In addition, there was no information on adverse events. We do not know if adding dexamethasone to ketorolac causes an increase, same or decrease number of adverse events. Without knowing the potential harms, it is difficult to put any potential benefits into proper context.
  5. Adjunct Medication? No information was provided if any adjunct medication was provided. Specifically, alpha-blockers like tamsulosin are still often used in many practice settings. While the goal of alpha blockers is for stone passage (and this is very controversial), they may also play a role in the management of renal colic as we see evidence of pain improvement in the setting of ureteral stents. It is unclear if patients were treated equally except for the addition of dexamethasone to the standard dose of ketorolac.

Comment on Authors’ Conclusion Compared to SGEM Conclusion: We think the authors are over-interpreting their evidence. Without additional information on how accurate the diagnosis, stone size and location, rate of adverse events and use of adjunct medication we should consider this preliminary data hypothesis generating.

SGEM Bottom Line: We cannot recommend the addition of dexamethasone to ketorolac in the treatment of adult patients with suspected renal colic.

Case Resolution: The patient is provided with 15mg IV ketorolac and her pain improves. The CT scan shows a 4mm stone at the ureterovesical junction without any hydronephrosis. She is discharged home with a prescription for ketorolac, strainer for urine, instructions on when to return and referred to urology for an outpatient consult.

Clinical Application: I will not be suggesting dexamethasone for patients presenting with suspected acute renal colic. I fully support ketorolac or NSAIDs in general as first line and this is certainly supported in the literature. I do applaud the consistency of this approach in this group.

What Do I Tell the Patient?  You have a small kidney stone. Most people will be able to pass this size of stone. We are going to give you a prescription for some pain medicine. If your pain gets worse, you can’t keep anything down, develop a fever or are worried please return to the ED. A referral has been sent to the urologist on-call and their office will contact you about an appointment.

Keener Kontest: Last weeks’ winner was Tim Kolosionek. He knew Inge Edler and Hellmuth Hertz are credited for publishing the first description of M-mode echocardiography in 1953.

Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.