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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether celecoxib (also known as Celebrex), combined with Tylenol, can manage pain after parotidectomy surgery as effectively as, or better than, oxycodone. Researchers aim to determine if celecoxib can reduce the need for stronger opioids. Participants will take either celecoxib or a placebo, along with Tylenol, and will record their pain levels. Individuals who have undergone a parotidectomy (a type of salivary gland surgery) and can take oral medication may be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that celecoxib is likely to be safe for humans?

Studies have shown that celecoxib is as safe as a placebo for managing post-surgery pain. In a large, multi-location trial, patients taking celecoxib reported no specific side effects. Another study found no major changes in pain levels or side effects, such as bleeding, when using celecoxib. These findings indicate that celecoxib is well-tolerated for post-surgery pain management. Celecoxib's FDA approval for treating pain and inflammation in other conditions further supports its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Celecoxib is unique because it targets COX-2 enzymes specifically, which helps in reducing inflammation and pain with potentially fewer side effects compared to traditional NSAIDs that target both COX-1 and COX-2 enzymes. This specific targeting can mean less risk of stomach issues, like ulcers, which are common with other pain medications. Researchers are excited about celecoxib for managing pain after parotidectomy because it could offer effective pain relief while minimizing the gastrointestinal side effects often associated with other pain relief medications like oxycodone and Tylenol.

What evidence suggests that celecoxib might be an effective treatment for pain after parotidectomy?

Research has shown that celecoxib, which participants in this trial may receive, can help manage pain after surgery, particularly for head and neck operations. Studies have found that using celecoxib soon after surgeries like the removal of tonsils and adenoids reduces the need for opioids and shortens hospital stays without causing additional side effects. One study found that celecoxib, when used alongside other pain management methods, safely reduces the need for narcotics in outpatient head and neck surgeries. Additionally, taking a higher dose of celecoxib before surgery has proven more effective in reducing severe pain and the need for extra pain medication. Overall, these findings suggest celecoxib is a promising option for managing post-surgical pain and reducing reliance on opioids. ^{1 3 4 6 7}

Who Is on the Research Team?

Tiffany Glazer, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06505187

NCT06505187 | Celecoxib for ENT Pain Management This study aims to determine if celecoxib is a viable alternative for acute pain control in the postoperative setting for head and neck surgeries which could ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11163914/

Evaluation of Postoperative Efficacy and Safety ... Using celecoxib early after an adenotonsillectomy has reduced both opioid use and duration of hospital stay without increasing adverse effects or bleeding.

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2657200

Multimodal Analgesia in Outpatient Head and Neck Surgery A multimodal analgesia strategy was feasible and safe in patients undergoing outpatient head and neck surgery and may reduce the need for narcotic use.

4. researchgate.net researchgate.net/publication/10748417_The_Efficacy_of_Celecoxib_Premedication_on_Postoperative_Pain_and_Recovery_Times_After_Ambulatory_Surgery_A_Dose-Ranging_Study

The Efficacy of Celecoxib Premedication on Postoperative ... We conclude that oral premedication with celecoxib 400 mg was more effective than 200 mg in reducing severe postoperative pain and the need for rescue analgesic ...

5. digitalcommons.pcom.edu digitalcommons.pcom.edu/cgi/viewcontent.cgi?article=1320&context=pa_systematic_reviews

Are Cox-2 Inhibitors Such as Celecoxib and Parecoxib ... This paper evaluates three double blind randomized controlled trials that compare the efficacy of celecoxib and parecoxib (Cox-2 inhibitors) as ...

6. withpower.com withpower.com/trial/phase-2-parotidectomy-8-2024-9bb42

Celecoxib for Pain After Parotidectomy In a multicenter, double-blind, randomized trial, Celecoxib showed a safety profile similar to placebo, with no specific adverse events reported. It is ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/coa.14177?af=R

Assessing the efficacy of celecoxib after tonsillectomy and/ ... Our results demonstrated that celecoxib is significantly linked to a decrease in post-operative pain. Additionally, celecoxib works better at ...