Podcast: Play in new window

Subscribe: RSS

Date: September 22, 2026

Dr. Sergey Motov

Guest Skeptic: Dr. Sergey Motov is an Emergency Physician in the Department of Emergency Medicine, Maimonides Medical Center in New York City. He is also one of the world’s leading researchers on pain management in the emergency department. 

Reference: Sharabun et al. Oral Ibuprofen Versus Intramuscular Ketorolac for Acute Musculoskeletal Back Pain in the Emergency Department: A Prospective Analysis. Journal of Pharmacy Practice. 2026

Case: A 42-year-old man presents to the emergency department (ED) with three days of severe lower back pain that started after moving boxes at work. There was no fall or direct trauma. He describes constant, non-radiating pain rated 8/10 that is worse with movement and is preventing him from sleeping and returning to work.

He denies fever, intravenous drug use, cancer, recent infection, weight loss, leg weakness, saddle anesthesia, or bowel or bladder dysfunction. His vital signs are normal. He has bilateral lumbar paraspinal tenderness, no midline tenderness, and an intact lower-extremity neurologic examination. He has not taken an analgesic or muscle relaxant in the preceding four hours and has no history of kidney disease, peptic ulcer disease, gastrointestinal bleeding, hepatic failure, or NSAID allergy.

You diagnose acute atraumatic musculoskeletal back pain and offer oral ibuprofen. He replies that pills never work for him and asks for the Toradol shot because it is stronger.

Background: Back pain is one of those emergency department (ED) complaints that can fill the waiting room, empty the medication cupboard, and still leave both the patient and clinician frustrated. Patients commonly present after lifting, twisting, shovelling, moving furniture, or sometimes with no memorable trigger at all. The pain can be severe enough to interfere with walking, sleeping, working, and activities of daily living. Most have no concerning neurologic findings or other red flags, but our first job remains identifying the uncommon patient with fracture, infection, malignancy, cauda equina syndrome, or another serious cause.

Once you have considered serious pathology, the next challenge is treatment. Unfortunately, there is no magic analgesic for uncomplicated acute low back pain. Acetaminophen, NSAIDs, corticosteroids, benzodiazepines, skeletal muscle relaxants, opioids, and various medication combinations have all been studied, generally producing small, inconsistent, or clinically unimpressive benefits. Non-pharmacologic approaches, including cognitive behavioural therapy, mindfulness, chiropractic manipulation, physiotherapy, acupuncture, massage, and most recently TENS, have also been tried. Some patients report benefit, but no single treatment has emerged as the reliable winner. The SGEM has returned to this topic repeatedly because low back pain is common, disabling, and stubbornly difficult to treat. 

NSAIDs remain a common starting point for eligible ED patients with acute musculoskeletal back pain. Oral ibuprofen is inexpensive, familiar, and easy to administer. Ketorolac is frequently given intravenously or intramuscularly and carries a certain aura of being faster, stronger, or somehow more serious medicine. Patients will sometimes specifically request the injection because they believe it must work better.

Route of administration can matter when a patient cannot swallow, is vomiting, must remain nil by mouth, or already has vascular access. However, a parenteral route does not automatically provide superior analgesia. It also comes with additional expense, administration time, injection pain, hematoma risk, and occupational needlestick risk. In 2000, Schwartz and colleagues examined whether the perception of receiving an injection created additional analgesia. Every participant unknowingly received 800 mg of ibuprofen in an orange-flavoured drink and was then randomized to a placebo pill or placebo saline injection. Pain relief was virtually identical between groups, with no evidence that the injection produced a selective placebo effect. Back pain patients were excluded from that study, so it addressed the psychology of route rather than this specific clinical population. 

Earlier ED trials comparing oral ibuprofen with IM ketorolac also generally failed to show better analgesia with the injectable option. However, many used 800 mg of ibuprofen and 60 mg of ketorolac, above the ceiling dose for both analgesics.

Clinical Question: In adults aged 21–65 years presenting to the ED with acute, atraumatic musculoskeletal back pain of at least moderate severity, does oral ibuprofen 400 mg provide similar pain reduction at 60 minutes to IM ketorolac 10 mg?

Reference: Sharabun et al. Oral Ibuprofen Versus Intramuscular Ketorolac for Acute Musculoskeletal Back Pain in the Emergency Department: A Prospective Analysis. Journal of Pharmacy Practice. 2026

  • Population: Adults (21-65) presenting to a single urban Bronx ED with acute, atraumatic musculoskeletal back pain lasting four weeks or less and a baseline VAS pain score of at least 50/100 mm.
    • Exclusions: Age under 21 or over 65; subacute pain lasting 4–12 weeks; chronic pain lasting over 12 weeks; pregnancy or breastfeeding; active peptic ulcer disease; acute GI hemorrhage; CKD stage IV or V; Child-Pugh B or C hepatic insufficiency; ESI category below 3; NSAID allergy; or receipt of another analgesic or skeletal muscle relaxant within four hours.
  • Intervention: Ibuprofen 400 mg oral suspension plus an IM placebo injection.
  • Comparison: Ketorolac 10 mg IM plus an oral placebo suspension.
  • Outcome:
    • Primary Outcome: Absolute change in 100-mm VAS pain score from baseline to 60 minutes.
    • Secondary Outcomes: Rescue analgesia at 60 minutes and adverse drug reactions. The investigators also reported administration of skeletal muscle relaxants and optional pain measurements at 90 and 120 minutes for patients who remained in the ED.
  • Type of Study: Prospective, single-centre, parallel-group, randomized, double-blind, double-dummy, active-comparator superiority

Authors’ Conclusions: “Ketorolac 10 mg IM and ibuprofen 400 mg PO seem to provide similar reductions in pain scores for the treatment of acute, atraumatic, musculoskeletal back pain. Further research is warranted to assess if there is similar reduction in pain scores for the treatment of acute, atraumatic, musculoskeletal back pain and other acute pain etiologies between ibuprofen and ketorolac.”

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. Unsure
  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). No
  6. The patients in both groups were similar with respect to prognostic factors. Unsure
  7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes
  8. All groups were treated equally except for the intervention. Yes
  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. Funding of the study? The authors stated that they received no financial support for the research, authorship or publication.
  13. Financial conflicts of interest. No COIs declared by the authors

Results: A total of 153 patients were considered. Sixty were excluded: 32 declined consent, 27 did not satisfy the inclusion criteria, and one left before completing the study period. Ninety-three participants were randomized (47 to ibuprofen and 46 to ketorolac). The median age was 42 years in both groups. Men made up 66% of the ibuprofen group and 59% of the ketorolac group. The population was racially and ethnically diverse. Baseline mean pain scores were high: 78/100 mm with ibuprofen and 84/100 mm with ketorolac.

Key Result: There was a significant decrease in pain with oral ibuprofen and IM ketorolac but no statistically significant difference between the two groups.

  • Primary Outcome: Absolute VAS pain reduction at 60 minutes
    • 35mm oral Ibuprofen vs 32mm IM ketorolac
    • Between-group mean difference of 3mm (95% CI; -8.03 to 15.03mm) p-0.27
  • Secondary Outcomes: There were no statistically significant differences in rescue acetaminophen or use of the reported skeletal muscle relaxants. Two ketorolac patients reported injection-site pain. No nausea, vomiting, diarrhea, headache or flushing was reported in either group during the brief observation period. The study was much too small and too short to assess uncommon renal, gastrointestinal or cardiovascular NSAID harms.

1. Randomization & Analysis: These were incompletely reported. The authors refer to a predetermined randomization table but do not say how it was generated or whether restrictions such as blocks or stratification were used. Allocation concealment appears reasonable, but proper sequence generation cannot be independently assessed. Intention-to-treat analysis was not explicitly stated, and protocol deviations or crossovers were not described. Using a STROBE cohort checklist rather than CONSORT may have contributed to these reporting gaps. Randomized trials can remain vulnerable to selection bias when sequence generation or concealment is inadequately described or implemented.

2. Non-consecutive Recruitment: Enrollment was limited to weekdays between 8 am and 10 pm when a pharmacist was available. Thirty-two otherwise potentially eligible patients declined participation. Patients younger than 21, older than 65, more acutely ill patients, and those with several common comorbidities were excluded. This may produce a study population different from patients presenting overnight, on weekends, or in community EDs. It particularly limits applicability to older adults, who are both frequent users of emergency care and at greater risk from NSAIDs. 

3. Not Statistically Superior: This trial used a conventional superiority analysis and did not detect a statistically significant difference between oral ibuprofen and IM ketorolac. Failure to demonstrate superiority is not the same as proving the treatments equivalent or non-inferior. The reported confidence interval suggests that the true difference could range from approximately 8 mm favouring ketorolac to 15 mm favouring ibuprofen. Whether that range represents clinically comparable analgesia depends on what between-group difference clinicians and patients consider important; the investigators did not prespecify such a margin. Nevertheless, the results make a large analgesic advantage for IM ketorolac unlikely

4. Route of Administration: This study did not isolate the route of administration. Two things changed simultaneously: the medication and the route. The trial compared oral liquid ibuprofen with IM ketorolac rather than comparing the same NSAID orally and intramuscularly. Any observed difference, or absence of difference, therefore, reflects the combined effects of drug, dose, formulation and route. In addition, the authors acknowledge that the 10-mg ketorolac ceiling was established for intravenous administration, not specifically for IM administration. Oral suspension also reaches peak concentration sooner than many tablets, so the study does not perfectly reproduce routine discharge prescribing. 

All patients received both an oral treatment and an IM injection as part of the double-dummy design. Any contextual analgesia associated with getting a shot could therefore have contributed to the improvement in pain in both groups (placebo response). However, because the injection ritual was common to both groups, it should largely cancel in the between-group comparison rather than create a false finding of similarity. The design strengthens the comparison of the active regimens but prevents the trial from determining whether knowingly receiving an injection provides additional contextual analgesia in routine practice.

The 2000 Schwartz trial directly examined that question by holding the active analgesic constant and varying the perceived route; it found no selective benefit from the IM injection, although back-pain patients were excluded. A same-drug route trial, ideally supplemented by active-placebo and no-treatment comparisons, would be needed to separate pharmacologic, route-related and contextual effects.

5. Outcomes: The primary outcome was a subjective pain score at 60 minutes. Pain matters, but so do mobility, functional recovery, return to work, sleep, patient satisfaction, repeat medication use, ED revisits and adverse events after discharge. These were not adequately assessed. We often must get people mobilized (road tested) prior to discharge. It is not enough to have less pain if they cannot yet transfer and ambulate out of the ED. Patients could leave after 60 minutes, even though the paper states that ketorolac may not reach peak analgesic effect until two to three hours. The small sample also means that the absence of serious adverse events provides little safety reassurance.

Comment on the Authors’ Conclusion Compared to the SGEM Conclusion: The authors’ conclusion seems reasonable and appropriately cautious.

SGEM Bottom Line: An IM ketorolac shot does not appear superior for 1-hour pain relief than oral ibuprofen in selected adults with acute atraumatic musculoskeletal back pain.

Case Resolution: You explain that both medications are NSAIDs and that the best available evidence does not show superior pain relief from the ketorolac injection at one hour. The shot adds injection pain and needle-related inconvenience without a demonstrated analgesic advantage.

After shared decision-making, the patient agrees to oral ibuprofen 400 mg. You set expectations that the goal is to decrease suffering and improve movement, not necessarily reduce his pain score to zero before discharge. He is reassessed, can stand and walk more comfortably, and is discharged with advice to remain gently active, arrange follow-up if symptoms persist, and return for new weakness, saddle sensory loss, bowel or bladder dysfunction, fever, significant trauma, or any other concerning deterioration.

Clinical Application: When adults resembling the study population present to the ED with back pain, can take an oral NSAID, and have no contraindications, start with the oral option and skip the poke.

However, the study does not say that IM ketorolac should never be used. The parenteral route may still be appropriate when the oral route is unavailable or impractical. What the study challenges is administering an injection solely because the clinician or patient believes that a shot must be stronger.

What Do I Say To the Patient? Your history and examination today do not suggest a dangerous cause for your back pain. An injection does not work better than an oral medication. The shot can hurt and has some additional needle-related downsides, without evidence that it will give you better relief. Since you can take medication by mouth and we have checked that an NSAID is safe for you, I recommend starting with oral ibuprofen. It should take the edge off, but it may not remove all the pain today. Gentle movement is usually better than prolonged bed rest, and we will give you clear instructions about symptoms that should bring you back.

Keener Kontest: Last week’s winner was Dr. Cindy Bitter. She knew why we call it acetaminophen in North America and paracetamol in many other parts of the world. 

Other SGEM Episodes:

  • SGEM#87: Let Your Backbone Slide – Paracetamol for Low-Back Pain
  • SGEM#173: Diazepam Won’t Get Back Pain Down
  • SGEM#175: Dancing on the Ceiling with Ketorolac for Pain, not back-pain specific but directly relevant to the ketorolac analgesic-ceiling discussion.
  • SGEM#187: Pin Cushion – Acupuncture in the Emergency Department, which included acute back-pain patients. 
  • SGEM#240: I Can’t Get No Satisfaction for My Chronic Non-Cancer Pain
  • SGEM#304: Treating Acute Low Back Pain – It’s Tricky, Tricky, Tricky
  • SGEM#342: Should We Get Physical, Therapy for Minor Musculoskeletal Disorders in the ED?
  • SGEM#366: Relax, Don’t Do It – Skeletal Muscle Relaxants for Low Back Pain
  • SGEM#419: Welcome Back – To Another Episode on Back Pain
  • SGEM#483: Electricity – TENS Units for Treating Back Pain

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