Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: St. Louis University
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
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.
What data supports the idea that Pain Medication for Postoperative Pain is an effective treatment?The available research shows that pain medications like acetaminophen, NSAIDs, and opioids are effective in managing postoperative pain. For example, a study found that a combination of oxycodone, acetaminophen, and ketorolac was effective in controlling pain after hand and wrist surgery. Another review highlighted that paracetamol and NSAIDs reduced the need for additional pain relief, like morphine, after surgery. These findings suggest that these drugs can effectively reduce pain and the need for stronger painkillers.346910
Is the drug Hydrocodone/Acetaminophen, Morphine, Oxycodone a promising option for postoperative pain relief?The drug Hydrocodone/Acetaminophen, Morphine, Oxycodone can be effective for short-term pain relief after surgery, as opioids are known to provide strong pain relief during the initial recovery period. However, other studies suggest that non-opioid pain relievers like acetaminophen and anti-inflammatory drugs can also be effective and may lead to a smoother recovery without the risk of addiction associated with opioids.1781113
What safety data exists for pain medication used in postoperative pain management?The safety data for pain medications used in postoperative pain management includes several studies. A trial comparing oxycodone/acetaminophen (Percocet) with controlled-release oxycodone (OxyContin) found that the combination provided enhanced analgesia and a better safety profile, with fewer adverse events. Another study highlighted the use of paracetamol in combination with tramadol for effective pain relief and reduced tramadol intake, especially beneficial for patients with increased ulcer risk. A review on multimodal analgesia emphasized the benefits of using intravenous acetaminophen and intranasal ketorolac, among others, for superior pain control with fewer side effects compared to opioids alone. Additionally, a systematic review compared the safety of intravenous oxycodone with other strong opioids like fentanyl and morphine for acute postoperative pain.2451012
Do I have to stop taking my current medications for the trial?The trial does not specify if you must stop all current medications, but you cannot participate if you are using probenecid, Pentoxifylline, or require anticoagulant or anti-platelet therapy. Also, certain medical conditions and medication allergies may exclude you from the trial.
Eligibility Criteria
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 18 years old or older.
I am planning to have surgery to prevent fractures in my thigh bone.
Exclusion Criteria
I have had peptic ulcer disease in the past.
I have a history of heart failure or heart disease.
I have had heart bypass surgery.
I am on chemotherapy that doesn't allow for NSAID use.
I have a fracture caused by my cancer.
I cannot use toradol due to my liver condition.
I am currently taking the medication probenecid.
I have had severe kidney problems in the past.
I have a blood clotting disorder or need blood-thinning medication during the study.
I am currently taking Pentoxifylline.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment6 Interventions
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.
Group II: ControlPlacebo Group6 Interventions
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.
Hydrocodone/Acetaminophen is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Vicodin for:
- Moderate to severe pain
🇨🇦 Approved in Canada as Hydrocodone/Acetaminophen for:
- Moderate to severe pain
🇪🇺 Approved in European Union as Hydrocodone/Acetaminophen for:
- Moderate pain
Find a clinic near you
Research locations nearbySelect from list below to view details:
Saint Louis UniversitySaint Louis, MO
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Who is running the clinical trial?
St. Louis UniversityLead Sponsor
References
Analgesics for pain relief after gynaecological surgery. A two-phase study. [2020]A two-phase, double-blind study was performed to assess the efficacy of various drugs in the relief of postoperative pain. Oral analgesia with two compounds (paracetamol 320 mg, caffeine 32 mg, codeine phosphate 8 mg and meprobamate 150 mg (Stopayne; Rio Ethicals) and dipyrone 500 mg, pitofenone hydrochloride 5 mg and fenpiverinium bromide 0,1 mg (Baralgan HS; Albert)) was found to produce satisfactory pain relief, and it is suggested that these oral compounds may be used from 12 hours postoperatively in uncomplicated cases. Parenteral administration of either pethidine 100 mg or dipyrone 2500 mg was found to be an ineffective form of pain relief, and it is suggested that the use of these drugs should be reviewed. In both phases of the study side-effects were infrequent and mild, and smoking did not have an influence on the results.
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]This randomized, controlled trial compared the analgesic efficacy and safety of the new oxycodone 10-mg/acetaminophen 325-mg formulation (Percocet) for the treatment of acute pain following oral surgery with double the dose of oxycodone alone (controlled-release [CR] oxycodone 20 mg [OxyContin]). A total of 150 male and female patients with > or = 2 full or partial bone-impacted mandibular molars, at least moderate persistent pain, and moderate trauma received a single dose of combination agent, CR oxycodone, or placebo following oral surgery and rated pain intensity and pain relief over the next 6 hours. The intent-to-treat population comprised 141 patients (55 on combination agent, 56 on oxycodone, and 30 on placebo). Combination agent and CR oxycodone were significantly superior to placebo for all efficacy measures. Combination agent was statistically superior to CR oxycodone in four of five outcome measures of pain intensity and pain relief (PPID, PPAR, SPID, and SPRID). It also provided a faster onset and 24% reduction in the number of patients reporting treatment-related adverse events compared with twice the dose of opioid alone. This new formulation offers the combination of two analgesic drugs with complementary mechanisms of action, which results in enhanced analgesia, an "opioid-sparing" effect, and an improved side effect and safety profile.
[New insights in postoperative pain therapy]. [2006]In this review, novel clinical studies on postoperative pain therapy are summarized. Based on these studies, several conclusions can be drawn: i) following tonsillectomy, postoperative therapy with NSAIDs leads to a significant increase in the number of reoperations; thus NSAIDs should be used with caution; ii) COX-2 inhibitors in combination with intravenous opioids improve recovery and functional outcome after knee replacement surgery; iii) the combination therapy of different non-opioid analgesics has no proven clinical efficacy and should not be used routinely; iv) patients' age is not a determinant in postoperative opioid titration after surgery; in contrast, it does predict opioid consumption during the first postoperative day; v) morphine and piritramide have identical analgesic efficacy and induce nausea and vomiting with the incidence; opioid selection can, thus, be based on economic considerations and vi) if tramadol is ineffective in postoperative pain therapy, this might be caused by an allelic variant of one of the cytochrome P450 enzymes (CYP2D6); these patients should be treated with a different opioid.
Efficacy of lornoxicam for acute postoperative pain relief after septoplasty: a comparison with diclofenac, ketoprofen, and dipyrone. [2022]To compare the efficacy of injectable lornoxicam with diclofenac, ketoprofen, and dipyrone for acute postoperative pain.
[Postoperative analgesia]. [2013]Data of 53 patients, operated on infrarenal aorta and large vessels were analyzed. Different combinations of nonopioid drugs were compared, used postoperatively. These were: ketoprofen+tramadol; lornoxicam+tramadol; paracetamol+tramadol; paracetamol+lornoxicam+tramadol. All of the combinations provided good analgesic effect. Inclusion of paracetamol allowed faster pain relief and decrease of tramadol intake. In patients with an increased ulcer risk, postoperative analgesia should be based on paracetamol and tramadol.
Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. [2022]In contemporary post-operative pain management, patients are most often treated with combinations of non-opioid analgesics, to enhance pain relief and to reduce opioid requirements and opioid-related adverse effects. A diversity of combinations is currently employed in clinical practice, and no well-documented 'gold standards' exist. The aim of the present topical, narrative review is to provide an update of the evidence for post-operative analgesic efficacy with the most commonly used, systemic non-opioid drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs)/COX-2 antagonists, glucocorticoids, gabapentinoids, and combinations of these. The review is based on data from previous systematic reviews with meta-analyses, investigating effects of non-opioid analgesics on pain, opioid-requirements, and opioid-related adverse effects. Paracetamol, NSAIDs, COX-2 antagonists, and gabapentin reduced 24 h post-operative morphine requirements with 6.3 (95% confidence interval: 3.7 to 9.0) mg, 10.2 (8.7, 11.7) mg, 10.9 (9.1, 12.8) mg, and ≥ 13 mg, respectively, when administered as monotherapy. The opioid-sparing effect of glucocorticoids was less convincing, 2.33 (0.26, 4.39) mg morphine/24 h. Trials of pregabalin > 300 mg/day indicated a morphine-sparing effect of 13.4 (4, 22.8) mg morphine/24 h. Notably, though, the available evidence for additive or synergistic effects of most combination regimens was sparse or lacking. Paracetamol, NSAIDs, selective COX-2 antagonists, and gabapentin all seem to have well-documented, clinically relevant analgesic properties. The analgesic effects of glucocorticoids and pregabalin await further clarification. Combination regimens are sparsely documented and should be further investigated in future studies.
Pain Relief After Operative Treatment of an Extremity Fracture: A Noninferiority Randomized Controlled Trial. [2017]Opioid pain medication is frequently given to patients recovering from a surgical procedure for an extremity fracture in spite of evidence that acetaminophen may be adequate. The aim of this study was to determine whether prescription of step 1 pain medication (acetaminophen) is noninferior to step 2 pain medication (acetaminophen and tramadol) after operative treatment of an extremity fracture.
Effective Postoperative Analgesia Using Intravenous Flurbiprofen and Acetaminophen. [2019]Management of postoperative pain is one of the most important components in postoperative care, because most patients have pain after dental surgery. The aim of this study was to evaluate whether acetaminophen could be an alternative to fentanyl in combination with a nonsteroidal anti-inflammatory drug (NSAID) as an analgesic after dental surgery in cases in which narcotic drugs were contraindicated.
Multi-Modal Pain Control in Ambulatory Hand Surgery. [2018]We evaluated postoperative pain control and narcotic usage after thumb carpometacarpal (CMC) arthroplasty or open reduction and internal fixation (ORIF) of the distal radius in patients given opiates with or without other non-opiate medication using a specific dosing regimen. A prospective, randomized study of 79 patients undergoing elective CMC arthroplasty or ORIF of the distal radius evaluated postoperative pain in the first 5 postoperative days. Patients were divided into 4 groups: Group 1, oxycodone and acetaminophen PRN; Group 2, oxycodone and acetaminophen with specific dosing; Group 3, oxycodone, acetaminophen, and OxyContin with specific dosing; and Group 4, oxycodone, acetaminophen, and ketorolac with specific dosing. During the first 5 postoperative days, we recorded pain levels according to a numeric pain scale, opioid usage, and complications. Although differences in our data did not reach statistical significance, overall pain scores, opioid usage, and complication rates were less prevalent in the oxycodone, acetaminophen, and ketorolac group. Postoperative pain following ambulatory hand and wrist surgery under regional anesthesia was more effectively controlled with fewer complications using a combination of oxycodone, acetaminophen, and ketorolac with a specific dosing regimen.
Updates on Multimodal Analgesia for Orthopedic Surgery. [2018]Pain control after orthopedic surgery is challenging. A multimodal approach provides superior analgesia with fewer side effects compared with opioids alone. This approach is particularly useful in light of the current opioid epidemic in the United States. Several new nonopioid agents have emerged into the market in recent years. New agents included in this review are intravenous acetaminophen, intranasal ketorolac, and newer nonsteroidal anti-inflammatory drugs, and the established medications ketamine and gabapentinoids. This article evaluates the evidence supporting these drugs in a multimodal context, including a brief discussion of cost.
A Tale of Two Knee Implants in the Same Person: Narcotics for the First and Anti-inflammatory Drugs for the Second. [2020]Opioid addiction is a world-wide tragedy, with severe consequences for both the victims and the society that must care for them. The pathways to addiction are multiple but postoperative opioid prescriptions for pain management are a major contributor to this crisis. This case report describes the differences in pain management during 2 different arthroplasties of the knees in the same person. After the first arthroplasty of the right knee 10 years ago, postoperative opioids were used, but after the second arthroplasty of the left knee in 2007, anti-inflammatory drugs took the place of opioids. The first postoperative treatment with opioids was marked by addiction and a nasty withdrawal. The recovery of knee function, driving, and return to work were prolonged. After the second arthroplasty in 2007, a combination of meloxicam (COX-2 inhibitor), high-dose acetaminophen (COX-1 inhibitor at higher doses), and diclofenac topical gel (COX-1 inhibitor with local effects) produced excellent pain control and significant reduction in swelling of the operated knee. The clinical course was smooth and recovery was rapid. The patient was walking normally and driving a car at 2 weeks and took an airplane trip at 4 weeks. After arthroplasty, postoperative opioids may not be necessary for most people.
Intravenous Oxycodone Versus Other Intravenous Strong Opioids for Acute Postoperative Pain Control: A Systematic Review of Randomized Controlled Trials. [2020]Optimal pain management is crucial to the postoperative recovery process. We aimed to evaluate the efficacy and safety of intravenous oxycodone with intravenous fentanyl, morphine, sufentanil, pethidine, and hydromorphone for acute postoperative pain.
Management of postsurgical pain in the community. [2021]Following surgery there is often a need for ongoing pain management after the patient is discharged from hospital. This can be made easier if the patient has an appropriate discussion before leaving hospital about what pain they can expect, and they are given a management plan Paracetamol and non-steroidal anti-inflammatory drugs are suitable for most patients. Drugs with a short half-life, such as ibuprofen, may need to be taken regularly Short-acting opioids can have a short-term role, providing guidelines are followed. There is a predictable period of time after surgery when the benefit of an opioid is expected to be maximised before harmful adverse effects will dominate Gabapentinoids are useful for neuropathic pain, but have a limited role in nociceptive pain. Like opioids, they have a risk of misuse The surgeon should be consulted if the patient develops new pain or the postoperative pain becomes more severe Most postsurgical pain will resolve within three months. If not, it is deemed persistent pain that may warrant specialist assessment