60 Participants Needed

Pain Medication for Postoperative Pain

SD
DG
AG
Overseen ByAllison Gruender, MSN
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether adding Toradol, an anti-inflammatory drug, to the usual opioid painkillers can better manage pain after surgery in patients who have had a specific type of bone surgery. These patients are chosen because they don't need the body's natural inflammation process for healing. Toradol works by reducing inflammation, while opioids change how the brain perceives pain. Toradol, also known as ketorolac, is a nonsteroidal anti-inflammatory drug (NSAID) that has been studied for its opioid-sparing effects in postoperative pain management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using probenecid or pentoxifylline, or if you have certain medical conditions that prevent NSAID or toradol use.

Is the pain medication safe for humans?

The combination of oxycodone and acetaminophen (Percocet) has been shown to have an improved safety profile with fewer side effects compared to oxycodone alone. Paracetamol (another name for acetaminophen) is also noted for providing effective pain relief with fewer side effects when used in combination with other pain medications.12345

How does the drug Hydrocodone/Acetaminophen, Morphine, Oxycodone differ from other drugs for postoperative pain?

This drug combination is unique because it includes both opioids (like Hydrocodone and Morphine) and non-opioid pain relievers (like Acetaminophen), providing a strong pain relief option for severe postoperative pain, but it carries a risk of addiction and side effects, unlike some non-opioid alternatives.678910

What data supports the effectiveness of the drugs for postoperative pain?

Research shows that a combination of oxycodone, acetaminophen, and ketorolac can effectively control postoperative pain with fewer complications compared to using opioids alone. Additionally, intravenous acetaminophen and intranasal ketorolac are highlighted as effective components in a multimodal approach to pain management after surgery.3451112

Who Is on the Research Team?

DG

David Greenberg, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

This trial is for adults planning to undergo prophylactic intramedullary nailing of the femur due to bone lesions. It's not suitable for those with coagulation disorders, current fractures, severe kidney or liver disease, peptic ulcer disease, certain heart conditions, allergies to acetaminophen or NSAIDs, opioid addiction or dependence, pregnancy, and those on specific medications like probenecid.

Inclusion Criteria

I have a bone lesion in my femur.
I am planning to have surgery to prevent fractures in my thigh bone.

Exclusion Criteria

You have a history of depending too much on or misusing opioid medications.
You are allergic to opioids and cannot use them.
You are allergic to acetaminophen.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive post-op pain management with either ketorolac and opioids or opioids alone following prophylactic intramedullary nailing of the femur

2 weeks
Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and functional assessments

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen
  • Hydrocodone/Acetaminophen
  • Ketorolac
  • Morphine
  • Oxycodone
Trial Overview The study investigates the effectiveness of using a pain reliever called Toradol in combination with opioids versus just opioids alone after surgery for securing weak bones in patients without fractures. The goal is to see if adding an NSAID can help manage post-op pain without affecting healing.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment6 Interventions
Group II: ControlPlacebo Group6 Interventions

Hydrocodone/Acetaminophen is already approved in United States, Canada, European Union for the following indications:

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Approved in United States as Vicodin for:
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Approved in Canada as Hydrocodone/Acetaminophen for:
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Approved in European Union as Hydrocodone/Acetaminophen for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials
197
Recruited
41,400+

Published Research Related to This Trial

In a study involving 200 patients undergoing elective septoplasty, lornoxicam was found to be effective in managing acute postoperative pain, but its efficacy was not superior to that of other nonopioid analgesics like diclofenac, ketoprofen, and dipyrone.
Patients receiving placebo required significantly more additional analgesia (pethidine) compared to those receiving active treatments, indicating that all active medications provided better pain relief than placebo, with no significant differences in adverse effects among the treatment groups.
Efficacy of lornoxicam for acute postoperative pain relief after septoplasty: a comparison with diclofenac, ketoprofen, and dipyrone.Sener, M., Yilmazer, C., Yilmaz, I., et al.[2022]
A multimodal approach to pain control after orthopedic surgery, which includes nonopioid agents like intravenous acetaminophen and intranasal ketorolac, offers better pain relief with fewer side effects compared to using opioids alone.
This review highlights the importance of incorporating newer nonopioid medications alongside established treatments like ketamine and gabapentinoids to enhance analgesia, especially in the context of the ongoing opioid epidemic.
Updates on Multimodal Analgesia for Orthopedic Surgery.Pitchon, DN., Dayan, AC., Schwenk, ES., et al.[2018]
Intravenous oxycodone was found to be more effective for managing acute postoperative pain compared to fentanyl and sufentanil, and it showed similar efficacy to morphine, based on a systematic review of 11 studies involving adult patients.
While oxycodone had a tendency for more side effects than fentanyl, its side effect profile was comparable to that of morphine and sufentanil, and patient satisfaction was generally higher with oxycodone compared to sufentanil.
Intravenous Oxycodone Versus Other Intravenous Strong Opioids for Acute Postoperative Pain Control: A Systematic Review of Randomized Controlled Trials.Raff, M., Belbachir, A., El-Tallawy, S., et al.[2020]

Citations

Efficacy of lornoxicam for acute postoperative pain relief after septoplasty: a comparison with diclofenac, ketoprofen, and dipyrone. [2022]
Updates on Multimodal Analgesia for Orthopedic Surgery. [2018]
Intravenous Oxycodone Versus Other Intravenous Strong Opioids for Acute Postoperative Pain Control: A Systematic Review of Randomized Controlled Trials. [2020]
Multi-Modal Pain Control in Ambulatory Hand Surgery. [2018]
[New insights in postoperative pain therapy]. [2006]
Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. [2019]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Postoperative analgesia]. [2013]
Effective Postoperative Analgesia Using Intravenous Flurbiprofen and Acetaminophen. [2019]
Pain Relief After Operative Treatment of an Extremity Fracture: A Noninferiority Randomized Controlled Trial. [2017]
Management of postsurgical pain in the community. [2021]
Analgesics for pain relief after gynaecological surgery. A two-phase study. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
A Tale of Two Knee Implants in the Same Person: Narcotics for the First and Anti-inflammatory Drugs for the Second. [2020]
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