Clinical trial · Interventional

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

NCT03823534CI-TRIAL-00109121recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bone Metastases	—	UNRESOLVED	—
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.92
Opioid Use	—	UNRESOLVED	—
Pain	—	UNRESOLVED	—

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
Acetaminophen	Drug	—	UNRESOLVED
Hydrocodone/Acetaminophen	Drug	—	UNRESOLVED
Ketorolac	Drug	—	UNRESOLVED
Morphine	Drug	—	UNRESOLVED
Normal saline	Drug	—	UNRESOLVED
Oxycodone	Drug	—	UNRESOLVED
Oxycodone Acetaminophen	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Experimental Arm
description
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.
interventionNames
1. Drug: Ketorolac
2. Drug: Acetaminophen
3. Drug: Oxycodone Acetaminophen
4. Drug: Morphine
5. Drug: Hydrocodone/Acetaminophen
6. Drug: Oxycodone
type
PLACEBO_COMPARATOR
label
Control
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Femoral Shaft or Neck bone lesion
2. 18 years old or greater
3. Plan to undergo prophylactic intramedullary nailing of one femur

Exclusion Criteria:

1. Concurrent pathologic fracture
2. History of advanced renal impairment (eGFR\<30mL/min)
3. History of Peptic Ulcer Disease with bleeding or requiring hospitalization
4. History of NSAID or aspirin allergy
5. Concurrent chemotherapy regimen that prevents NSAID use
6. History of liver disease that precludes use of toradol
7. History of heart failure or cardiovascular disease that precludes toradol usage
8. Pregnancy
9. History of narcotic allergy resulting in anaphylaxis
10. Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study.
11. Patients with acetaminophen allergies resulting in anaphylaxis
12. Current use of the medication probenecid
13. Current use of the medication Pentoxifylline
14. History of aspirin induced asthma.
15. Known history of opioid dependence, abuse, or addiction.
16. Bilateral IMN of the femurs

References

Publications (1)

BACKGROUNDCepeda MS, Carr DB, Miranda N, Diaz A, Silva C, Morales O. Comparison of morphine, ketorolac, and their combination for postoperative pain: results from a large, randomized, double-blind trial. Anesthesiology. 2005 Dec;103(6):1225-32. doi: 10.1097/00000542-200512000-00018. PMID 16306736

Registry

Dates and enrollment

Start: Feb 20, 2019
Primary completion: Dec 31, 2026
Completion: Mar 31, 2027
First posted: Jan 30, 2019
Last update posted: Apr 22, 2026
Enrollment: 60 (estimated)
Lead sponsor: St. Louis University OTHER
Keywords: Toradol, Ketorolac, Prophylactic intramedullary nail, bone metastases, Opioid use, post-operative pain

Data updated 22 days agoSource updated Apr 22, 2026source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.