Pain Management Medications for Postoperative Pain

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Disqualifiers: Pregnancy, Lactation, Past nasal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage pain after nose surgery by comparing two different painkiller combinations. One group will take a mix of Acetaminophen and Hydrocodone (known as Norco), while the other will use Acetaminophen and Ibuprofen. Researchers will track how well each combination controls pain, the number of pills participants take, and any side effects. Candidates may qualify if they have undergone nose surgery for cosmetic reasons or to fix breathing problems and can speak English. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of hydrocodone and acetaminophen, as found in Norco, is often used to manage moderate to severe pain and proves effective after surgery. However, it can cause serious side effects and overdose, particularly in those unaccustomed to strong painkillers. These side effects include nausea, dizziness, or more severe reactions.

In contrast, studies have found that combining acetaminophen and ibuprofen also effectively reduces post-surgical pain. This combination is generally gentler on the body, with fewer risks compared to opioids. Common side effects might include an upset stomach or mild allergic reactions.

Both treatments are used for pain management but present different safety concerns. The choice often depends on balancing pain relief needs with potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for postoperative pain because they explore the combined use of Tylenol and Ibuprofen, offering a potential alternative to opioids like Norco. Unlike typical opioid treatments, which can carry risks of addiction and side effects, the combination of Tylenol and Ibuprofen targets pain through different pathways without involving opioids. This approach could provide effective pain relief while minimizing the risk of dependency, making it a safer option for managing postoperative pain.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

Research has shown that Norco, a combination of hydrocodone and acetaminophen, effectively manages moderate-to-severe pain after surgery. It is often used when other pain medicines are insufficient. In this trial, participants in Drug Arm A will receive Norco. Conversely, participants in Drug Arm B will receive a combination of Tylenol (acetaminophen) and ibuprofen, which has also demonstrated strong pain relief. Studies suggest that this combination can sometimes match or surpass the effectiveness of opioids. Both treatments have evidence supporting their pain management capabilities, with effectiveness varying by situation. ^{1 2 3 5 6}

Who Is on the Research Team?

SAM P Most, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English and are having rhinoplasty either for cosmetic reasons or to treat nasal obstruction. It excludes pregnant or lactating women, those with allergies to pain meds used in the study, and anyone not undergoing nasal surgery.

Inclusion Criteria

I am planning to have a nose job for cosmetic reasons.

Able to speak and understand English

I am having a nose surgery to fix my blocked nose.

Exclusion Criteria

I am under 18 years old.

I am not planning to have nasal surgery.

Cannot speak and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Norco or Tylenol with Ibuprofen for postoperative pain management for 5 days

5 days

Daily self-reporting of pain intensity and side effects

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ibuprofen 200 mg
• Norco 5Mg-325Mg Tablet
• Postoperative Pain Management
• Rhinoplasty
• Tylenol 325Mg Caplet

Trial Overview The study compares postoperative pain control using two combinations of medications after nasal surgery: Acetaminophen (325mg) + Hydrocodone (5mg) versus Acetaminophen (325mg) + Ibuprofen (200mg), taken over a period of 5 days.

How Is the Trial Designed?

Group I: Drug Arm A Active Control 1 Intervention

Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total

Group II: Drug Arm B Active Control 2 Interventions

Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

NSAIDs are generally more effective than paracetamol for pain relief in dental surgery, while their effectiveness is similar in major and orthopedic surgeries, indicating that the choice of pain management may depend on the type of surgery.

Paracetamol is a safer alternative to NSAIDs due to its lower incidence of adverse effects, making it a preferred option for high-risk patients; combining paracetamol with NSAIDs may enhance pain relief, but more research is needed to assess potential side effects from this combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. Hyllested, M., Jones, S., Pedersen, JL., et al.[2022]

Ibuprofen is an effective and safe option for managing mild to moderate postoperative pain, as demonstrated in controlled clinical trials.

In a study involving 120 patients with postoperative orthopedic pain, ibuprofen outperformed acetaminophen-codeine in effectiveness and provided longer-lasting relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of postoperative pain. Slavic-Svircev, V., Heidrich, G., Kaiko, RF., et al.[2020]

Effective pain management after surgery involves pre-discharge discussions about expected pain and a clear management plan, with paracetamol and non-steroidal anti-inflammatory drugs being suitable for most patients.

While short-acting opioids can be used for a limited time post-surgery, they must be carefully monitored due to the risk of adverse effects and misuse, and gabapentinoids are primarily effective for neuropathic pain rather than nociceptive pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of postsurgical pain in the community. MacPherson, R., Pattullo, G.[2021]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538530/

Hydrocodone and Acetaminophen - StatPearls - NCBI Bookshelf Hydrocodone is a potent analgesic commonly prescribed for moderate-to-severe pain management in postoperative settings, trauma patients, and

2. mayoclinic.org mayoclinic.org/drugs-supplements/hydrocodone-and-acetaminophen-oral-route/description/drg-20074089

Hydrocodone and acetaminophen (oral route) Hydrocodone and acetaminophen combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acem.12813

Comparative Analgesic Efficacy of Oxycodone ... The primary outcome was the between-group difference in improvement in numerical rating scale (NRS) pain scores over a 2-hour period following ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/040099s023lbl.pdf

NORCO® Hydrocodone Bitartrate and Acetaminophen ... NORCO is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of ...

5. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... Opioid therapy is associated with small improvements in short-term (duration of 1 to <6 months) pain and function compared with placebo, with ...

6. publications.aap.org publications.aap.org/pediatriccare/drug-monograph/18/5487/Hydrocodone-and-Acetaminophen

Hydrocodone and Acetaminophen | Drug Lookup There are no data on the safety and efficacy of hydrocodone/acetaminophen combination therapy in patients with kidney impairment. The use of acetaminophen ...