A Phase 3 interventional study of Ketorolac and Normal saline in Bone Metastases, Lymphoma and Multiple Myeloma, sponsored by St. Louis University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by St. Louis University · Phase 3, Interventional, and Treatment
Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.
Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails, often due to bone metastases that increase risk for future fractures. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use.
Recent literature has demonstrated the efficacy of multi-modal pain management in treating post-op pain [1]. Currently, patients that undergo prophylactic intramedullary femur nail placement at SLU are often treated with both narcotics and toradol, as long as they can tolerate NSAIDs. However, the effect of toradol in addition to narcotics has not been determined. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's planned enrollment of 60 is above the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →St. Louis University is the lead sponsor of 156 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the first 24 hours following surgery, patients younger than 65 years old will be administered a maximum of 120 mg/day bolus IV ketorolac (30 mg every 6 hours). Patients older than 65 years old or with history of advanced renal impairment will receive a maximum of 60 mg/day bolus IV ketorolac (15 mg every 6 hours). All patients may also be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate- severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. At discharge, they will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours, quantity 50. Those with preexisting liver disease will be prescribed the equivalent in oxycodone and will not receive acetaminophen for mild pain.
Drug: Ketorolac · Drug: Acetaminophen · Drug: Oxycodone Acetaminophen · Drug: Morphine · Drug: Hydrocodone/Acetaminophen · Drug: Oxycodone
Following surgery, patients will be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate-severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. They will also be given a placebo injection of normal saline every 6 hours for the first 24 hours following surgery. At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours PRN quantity 50, unless they have preexisting liver disease, in which case they will be prescribed the equivalent in oxycodone. They will not receive a nerve block.
Drug: Normal saline · Drug: Acetaminophen · Drug: Oxycodone Acetaminophen · Drug: Morphine · Drug: Hydrocodone/Acetaminophen · Drug: Oxycodone
IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
Also known as: Toradol
An IV normal saline placebo prepared by the hospital pharmacy.
Also known as: Placebo
acetaminophen 500 mg PO Q4 hours PRN for mild pain
Also known as: Tylenol
oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
Also known as: Percocet
morphine IV PRN (or other opioid) for severe breakthrough pain
At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours. Those with preexisting liver disease will be prescribed the equivalent in oxycodone.
Also known as: Norco
Upon discharge, patients will be prescribed the equivalent of 1-2 hydrocodone 5mg Q4 hours upon should they have preexisting liver disease and are unable to consume acetaminophen.
Milligram Morphine Equivalent (MME) of Opioid Medications Utilized
Measure the effect of post-op ketorolac on the concurrent use of opioid pain medications during post-op days 1-14 following prophylactic IMN of the femur compared to patients treated only with opioids.
Time frame: Post-op days 1-14
Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale
Measure the effect of post-op ketorolac on PROMIS Pain Intensity score compared to the PROMIS of those that receive only opioids. Total scores are computed by summing the scores of the 3 individual questions. Possible scores range from 3-15 with higher values representing increasing pain over the previous 7 days.
Time frame: Up to six weeks post-op
Single Assessment Numerical Evaluation (SANE)
Measure the effect of post-op ketorolac on SANE score compared to the SANE of those that receive only opioids. The score ranges from 0-100, with 100 representing the best possible perceived function of the limb and 0 the worst possible perceived function. There are no sub-scales.
Time frame: Up to six weeks post-op
Numerical Rating Scale (NRS)
Measure the effect of post-op ketorolac on NRS score compared to the NRS of those that receive only opioids. Scores range from 0-10 with higher scores signifying increasing pain. There are no sub-scales.
Time frame: Up to six weeks post-op
Plan to share: No
Started Feb 2019 (actual). Primary completion is estimated for Dec 2026, 94 months after the start.
Of 33 non-industry phase 3 interventional studies under Lymphoma, half reached primary completion within 89 months of starting (the median), counting those still running; a quarter within 59 and three quarters within 116. This study's planned 94 months is close to that.
Counting every sponsor, half of 62 studies reached it within 67 months; a quarter within 52 and three quarters within 106.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ketorolac