Celecoxib for Pain After Parotidectomy

Overseen By Hayley Mann, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: CYP2C9 inhibitors

Disqualifiers: Congestive heart failure, Hypertension, Pregnancy, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

84 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are using CYP2C9 potentiators/inhibitors or investigational drugs within 30 days before the trial.

What data supports the idea that Celecoxib for Pain After Parotidectomy is an effective drug?

The available research does not provide specific data on the effectiveness of Celecoxib for pain after parotidectomy. The studies focus on surgical techniques, complications, and patient safety related to parotidectomy, but do not mention Celecoxib or compare it to other pain treatments for this condition. ^{1 2 3 4 5}

What safety data is available for Celecoxib?

Celecoxib, a selective COX-2 inhibitor, has been evaluated for safety in various studies. In a multicenter, double-blind, randomized trial, Celecoxib showed a safety profile similar to placebo, with no specific adverse events reported. It is considered a safer alternative to nonselective NSAIDs, offering improved gastrointestinal tolerability. However, there is inconsistent evidence regarding an increase in cardiovascular risk, which is likely small and similar to that of nonselective NSAIDs. Celecoxib should be used at the lowest effective dose for the shortest duration, especially in patients at low cardiovascular risk who require NSAID therapy. ^{6 7 8 9 10}

Is the drug Celecoxib a promising treatment for pain after parotidectomy?

Yes, Celecoxib is a promising drug for pain relief after surgery. Studies show that a higher dose of Celecoxib significantly reduces pain and the need for additional pain medication compared to lower doses or no treatment. It also helps in reducing the use of stronger painkillers like opioids, which can have more side effects. ^{9 11 12 13 14}

What is the purpose of this trial?

The goal of this clinical trial is to find out whether pain can be managed after an operation with celecoxib instead of oxycodone. The main question it aims to answer is if use of celecoxib plus Tylenol reduces the need for oxycodone. Researchers will compare the combination of celecoxib and Tylenol to a placebo to find out whether celecoxib works to manage pain. Participants will: * Take celecoxib, or a placebo, plus Tylenol with opioids as needed * Keep a diary of their pain between visits * Complete questionnaires

Research Team

Tiffany Glazer, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for adults who can consent to treatment, take oral medication, and are undergoing a superficial parotidectomy. They must be willing to follow the study's procedures, keep a pain diary, complete questionnaires, and have good organ function as shown by blood tests.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Willing to comply with all study procedures and be available for the duration of the study

I can take pills by mouth.

Exclusion Criteria

Use of investigational drugs, biologics, or devices within 30 days prior to randomization

Individuals who are pregnant, lactating or planning on becoming pregnant during the study

Not suitable for study participation due to other reasons at the discretion of the investigators

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive celecoxib or placebo in addition to Tylenol and oxycodone as needed for pain management

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain diary and questionnaires

1 week

1 visit (in-person)

Treatment Details

Interventions

• Celecoxib

Trial Overview The trial is testing if celecoxib combined with Tylenol can manage pain after surgery and reduce the need for oxycodone. Participants will either receive celecoxib or a placebo alongside Tylenol and use opioids only if necessary.

Participant Groups

Group I: Celecoxib for pain management Experimental Treatment 3 Interventions

Participants receive celecoxib in addition to Tylenol and oxycodone

Group II: Placebo for pain management Placebo Group 3 Interventions

Participants receive placebo in addition to Tylenol and oxycodone

Celecoxib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Celebrex for:

• Pain relief
• Inflammation
• Osteoarthritis
• Rheumatoid arthritis
• Menstrual cramps
• Colorectal polyps prevention

Approved in European Union as Celebrex for:

• Symptomatic relief in osteoarthritis
• Symptomatic relief in rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain
• Primary dysmenorrhea
• Adenomatous polyposis coli

Approved in Canada as Celebrex for:

• Symptomatic relief of osteoarthritis
• Symptomatic relief of rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain
• Primary dysmenorrhea

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

Outpatient parotidectomies, analyzed in a study of 4,368 cases, showed lower rates of surgical complications (1.8%) compared to inpatient procedures (3.1%), suggesting they may be a safer option for patients.

After matching for demographics and preoperative conditions, outpatient procedures also had significantly lower overall complication rates (2.6% vs. 4.5%), indicating that outpatient parotidectomies can be as effective as inpatient ones with fewer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient versus inpatient parotidectomy: Comparison of postoperative complication rates. Siddiqui, SH., Singh, R., Siddiqui, E., et al.[2019]

Parotidectomy remains the primary treatment for parotid gland tumors, and recent advancements in surgical techniques and perioperative care aim to enhance patient safety and outcomes.

The review highlights the importance of evaluating preoperative diagnostics, intraoperative methods, and postoperative care to improve the overall quality of parotidectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety and quality improvements in parotid surgery. Talati, V., Brown, HJ., Losenegger, T., et al.[2022]

First bite syndrome (FBS) occurs in about 6.3% of patients after parotidectomy for benign tumors, indicating it is a rare but significant complication that can affect quality of life.

Risk factors for developing FBS include being female, younger age, specific tumor locations, and having pre-surgery symptoms, with a potential link to cranial nerve VII paresis post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First bite syndrome after parotidectomy: a single-centre experience. Lammek, K., Tretiakow, D., Skorek, A.[2021]

Outpatient parotidectomy can be performed safely, with 95% of patients discharged the same day and no complications directly related to the outpatient procedure, indicating its efficacy as a treatment option.

While outpatient procedures resulted in average savings of $196 compared to a one-night inpatient stay, patient satisfaction was higher among inpatients, suggesting that while outpatient surgery is safe and cost-effective, inpatient care may offer a better overall experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient parotidectomy at the Fallon Clinic. The first 2 years. Bentkover, SH., Kozlicak, BA., Girouard, S.[2019]

Outpatient parotidectomy is a safe option for patients, with a similar complication rate to inpatient surgery; only 9 out of 144 patients experienced complications, with no significant difference between the two groups.

The study found that tumor size of 4.62 cm³ or larger was linked to the need for drain placement, suggesting that careful patient selection based on tumor size is important for outpatient procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient Parotidectomy: A Retrospective Series. Michel, MC., Mulcahy, CF., Benito, DA., et al.[2022]

In a study involving 616 Japanese patients with postoperative pain, celecoxib demonstrated a significantly higher efficacy rate (76.2%) compared to placebo (63.7%) and was also superior to etodolac (68.0%), indicating its effectiveness in managing acute pain.

Celecoxib was found to have a safety profile similar to that of placebo, with no specific adverse events reported, suggesting it is a safe option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of celecoxib compared with placebo and etodolac for acute postoperative pain: a multicenter, double-blind, randomized, parallel-group, controlled trial. Ishiguro, N., Hanaoka, A., Okada, T., et al.[2019]

In a pooled analysis of three trials involving 358 patients, parecoxib was found to have a low occurrence of treatment-emergent adverse events (TEAEs) when used for more than 3 days for postoperative pain management.

The frequency and severity of TEAEs after day 3 were similar between parecoxib and placebo groups, indicating that parecoxib is safe for extended use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of parecoxib when used for more than 3 days for the management of postoperative pain. Essex, MN., Cheung, R., Li, C., et al.[2018]

In a phase 3 clinical trial involving 80 adult patients post-tonsillectomy, celecoxib did not show any significant improvement in pain management compared to placebo, as measured by pain scores and narcotic intake.

Patients taking celecoxib experienced significantly more vomiting than those on placebo, indicating a potential safety concern with its use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is celecoxib a useful adjunct in the treatment of post-tonsillectomy pain in the adult population? A randomised, double-blind, placebo-controlled study. Ng, TT., Diamantaras, D., Priestley, J., et al.[2017]

High-dose celecoxib (6 mg/kg/dose) effectively reduces pain after pediatric tonsillectomy, particularly in children experiencing prolonged pain, without increasing the risk of bleeding or other adverse effects.

The study showed that children taking celecoxib consumed 52% less narcotic pain medication compared to those on placebo, indicating its potential as a safer alternative to traditional pain relief methods like ibuprofen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Celecoxib for Pain After Pediatric Tonsillectomy: A Randomized Controlled Trial. Giordano, T., Durkin, A., Simi, A., et al.[2023]

Celecoxib is an effective treatment for various types of arthritis and pain management, offering improved gastrointestinal tolerability compared to nonselective NSAIDs, making it a safer option for patients at risk of GI issues.

While there is some inconsistency regarding its cardiovascular risk, any potential increase is likely small and comparable to that of nonselective NSAIDs, suggesting celecoxib is a reasonable choice for patients with low cardiovascular risk who need NSAID therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Celecoxib: a review of its use in the management of arthritis and acute pain. Frampton, JE., Keating, GM.[2021]

In a study of 93 healthy outpatients undergoing minor surgery, celecoxib 400 mg was found to be significantly more effective than 200 mg and placebo in reducing postoperative pain and the need for additional pain relief medication.

Both doses of celecoxib (200 mg and 400 mg) reduced the requirement for fentanyl compared to placebo, but neither dose improved recovery times or patient satisfaction after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of celecoxib premedication on postoperative pain and recovery times after ambulatory surgery: a dose-ranging study. Recart, A., Issioui, T., White, PF., et al.[2021]

In a study of 40 patients undergoing uvulopalatopharyngoplasty (UPPP) for obstructive sleep apnea, those who received intravenous parecoxib in addition to local ropivacaine experienced significantly lower pain scores at 24 and 48 hours post-surgery compared to those who only received local anesthesia.

The combination of parecoxib and local anesthesia was effective in managing postoperative pain without increasing the risk of adverse reactions, indicating a safe and effective analgesic strategy for this surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of parecoxib in post-uvulopalatopharyngoplasty analgesia. Xie, GL., Chu, QJ., Liu, CL.[2018]

In a study of 60 children undergoing tonsillectomy, intravenous parecoxib sodium significantly reduced the need for rescue morphine compared to a placebo, with only 57% of children in the parecoxib group requiring morphine versus 83% in the placebo group.

Parecoxib also delayed the time to first rescue analgesic and resulted in lower pain scores and reduced incidence of postoperative nausea and vomiting, making it an effective option for managing postoperative pain in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parecoxib sodium reduces the need for opioids after tonsillectomy in children: a double-blind placebo-controlled randomized clinical trial. Li, X., Zhou, M., Xia, Q., et al.[2016]

In a study of 51 patients undergoing rhinoplasty, those who received celecoxib used significantly fewer opioids post-surgery, with a 76.2% reduction in opioid consumption compared to those who did not receive celecoxib.

Celecoxib also led to an 83.4% decrease in postoperative nausea and vomiting, demonstrating its effectiveness in managing pain and side effects without increasing surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Oral Celecoxib Following Surgical Rhinoplasty. Newberry, CI., McCrary, HC., Cerrati, EW.[2020]

References

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

Outpatient versus inpatient parotidectomy: Comparison of postoperative complication rates. [2019]

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

Patient safety and quality improvements in parotid surgery. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

First bite syndrome after parotidectomy: a single-centre experience. [2021]

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

Outpatient parotidectomy at the Fallon Clinic. The first 2 years. [2019]

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

Outpatient Parotidectomy: A Retrospective Series. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Efficacy and safety of celecoxib compared with placebo and etodolac for acute postoperative pain: a multicenter, double-blind, randomized, parallel-group, controlled trial. [2019]

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

Safety of parecoxib when used for more than 3 days for the management of postoperative pain. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Is celecoxib a useful adjunct in the treatment of post-tonsillectomy pain in the adult population? A randomised, double-blind, placebo-controlled study. [2017]

9. England pubmed.ncbi.nlm.nih.gov

High-Dose Celecoxib for Pain After Pediatric Tonsillectomy: A Randomized Controlled Trial. [2023]

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

Celecoxib: a review of its use in the management of arthritis and acute pain. [2021]

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

The efficacy of celecoxib premedication on postoperative pain and recovery times after ambulatory surgery: a dose-ranging study. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Application of parecoxib in post-uvulopalatopharyngoplasty analgesia. [2018]

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

Parecoxib sodium reduces the need for opioids after tonsillectomy in children: a double-blind placebo-controlled randomized clinical trial. [2016]

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

The Efficacy of Oral Celecoxib Following Surgical Rhinoplasty. [2020]