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

130 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drugs used for postoperative pain management in the clinical trial?

Research shows that ibuprofen and acetaminophen are effective for managing postoperative pain, as seen in dental and orthopedic surgeries. Combining ibuprofen with acetaminophen has been recommended for acute pain relief, and ibuprofen alone has been found to be more effective than some opioid combinations for postoperative pain. ^{1 2 3 4 5}

Is ibuprofen safe for managing postoperative pain?

Ibuprofen is considered safe for managing mild to moderate postoperative pain, especially at low doses used over-the-counter, with fewer gastrointestinal risks compared to other similar drugs. ^{1 3 6 7 8}

How does the drug combination of Ibuprofen 200 mg and Tylenol 325 mg differ from other postoperative pain treatments?

This drug combination is unique because it uses both ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and Tylenol (acetaminophen), which work together to manage pain without the side effects associated with opioids. Ibuprofen is effective for mild to moderate pain and has a longer duration of action compared to some other pain medications, while Tylenol is commonly used for pain relief and can reduce the need for stronger painkillers. ^{3 4 5 9 10}

What is the purpose of this trial?

The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications . Additionally, the study will also seek to track: 1. The total number of pills each patients consume from the prescribed 5 day regimen. 2. Any associated side effects. 3. Additional pain medications prescribed in case of inadequate pain control, postoperatively.

Research Team

SAM P Most, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Multicenter clinical trial of ibuprofen and acetaminophen in the treatment of postoperative dental pain. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Combining ibuprofen and acetaminophen for acute pain management after third-molar extractions: translating clinical research to dental practice. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of postoperative pain. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Effect of Intravenous Acetaminophen in Multimodal Analgesia After Total Hip Arthroplasty: A Randomized Controlled Trial. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Management of postsurgical pain in the community. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Ibuprofen: a journey from prescription to over-the-counter use. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ibuprofen Plus Paracetamol in a Fixed-Dose Combination for Acute Postoperative Pain in Adults: Meta-Analysis and a Trial Sequential Analysis. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Ibuprofen for pain treatment following dental surgery. A comparative prospective randomized study]. [2013]