Comparison of morphine, ketorolac, and their combination for postoperative pain: results from a large, randomized, double-blind trial.
Maria Soledad Cepeda, Daniel B Carr, Nelcy Miranda...
https://pubmed.ncbi.nlm.nih.gov/16306736/Actively Recruiting
Led by St. Louis University · Updated on 2026-04-22
60
Participants Needed
1
Research Sites
12 weeks
Total Duration
The opioid crisis has become a significant national epidemic with rising death rates each year. Orthopedic surgeons often prescribe narcotics instead of NSAIDs for post-operative pain due to concerns about delayed healing and nonunion. However, in orthopedic oncology, some patients receive prophylactic intramedullary femoral nails without existing fractures, allowing for the potential use of NSAIDs after surgery. This study aims to evaluate the effects of adding post-operative toradol, an NSAID, to opioids compared to using opioids alone for pain control in these patients. Participants are randomly assigned to one of two groups. In the experimental group, patients younger than 65 receive up to 120 mgday of intravenous ketorolac toradol in divided doses every 6 hours during the first 24 hours after surgery those 65 or older or with advanced kidney impairment receive a lower dose. All patients may also receive acetaminophen, oxycodone-acetaminophen, and morphine as needed while hospitalized, and hydrocodone-acetaminophen or oxycodone at discharge depending on liver function. The control group receives the same pain medications but a placebo saline injection instead of toradol. No nerve blocks are used. During the study, researchers track opioid use measured as milligram morphine equivalents over the first 14 days after surgery. They also assess pain intensity and functional outcomes up to six weeks post-operation using patient-reported scales like PROMIS Pain Intensity, SANE, and Numerical Rating Scale. Safety monitoring includes observing for medication tolerability and adverse effects. The study is sponsored by St. Louis University and continues until March 2027.
CONDITIONS
Post-Op Pain Control for Prophylactic Intramedullary Nailing.
D
David Greenberg, MD
A
Allison Gruender, MSN
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
St. Louis University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Ketorolac plus opioids | Placebo plus opioids | Opioid‑only standard care |
|---|---|---|---|
| What it is | Intravenous ketorolac given in addition to standard opioid pain medications after prophylactic femoral nailing | Intravenous normal saline placebo given in addition to standard opioid pain medications | Postoperative pain typically managed with opioids alone |
| Role in trial | Experimental intervention arm | Control arm with placebo infusion | Reflects common clinical management outside trial |
| Primary use | Post‑operative pain control after prophylactic femoral nail placement | Post‑operative pain control following prophylactic femoral nail placement | Post‑operative pain management following femoral surgery |
| How it is given or performed | Intravenous ketorolac infusion during the first 24 hours post‑surgery, plus opioid pain medications per IP provisions | Intravenous normal saline infusion during first 24 hours post‑surgery, plus opioid pain medications | Opioid pain medications alone, as per usual postoperative prescribing |
| Evidence status | Effect on opioid consumption and pain remains under investigation in this trial | Placebo arm under evaluation for contrast versus ketorolac arm | NSAIDs like ketorolac can reduce opioid requirements in postoperative fracture pain without significantly increasing nonunion risk when used short‑term |
| Important risks | Short‑term ketorolac use may carry theoretical risks of impaired bone healing, though evidence in fracture healing is limited | Normal saline placebo has no safety risk beyond standard opioid regimen | Opioid use is associated with risks of dependence, side effects, and may also impair bone healing |
| Important limitations | Trial results not yet available to confirm analgesic benefit or opioid‑sparing effect | Placebo control may not reflect real‑world practice where NSAIDs are often used adjunctively | Opioid‑only regimens may provide less multimodal analgesia than NSAID‑adjunct protocols |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - First 24 hours after surgery for IV intervention; pain control medications used up to 14 days post-op
Participants undergo prophylactic intramedullary femur nailing surgery and receive post-operative pain control with either IV ketorolac or placebo, along with additional pain medications as needed while hospitalized. Pain medication prescriptions continue at discharge.
1 surgery visit plus daily hospital visits during first 24 hours and medication use through post-op day 14
Duration - Up to 6 weeks post-op
Participants are monitored for pain intensity and recovery using patient-reported outcome measures up to six weeks after surgery.
Periodic follow-up visits during 6 weeks post-op
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Maria Soledad Cepeda, Daniel B Carr, Nelcy Miranda...
https://pubmed.ncbi.nlm.nih.gov/16306736/St. Louis University
Lead Sponsor