Celecoxib vs. Acetaminophen/Codeine/Caffeine for Post-operative Analgesia in Rhinoplasty.

Last updated: August 2, 2020
Sponsor: Blake Raggio
Overall Status: Active - Recruiting

Phase

4

Condition

Drug Use

Treatment

N/A

Clinical Study ID

NCT04259333
16511
  • Ages 18-80
  • All Genders

Study Summary

The primary aim of this study is to evaluate whether celecoxib (CELEBREX) is equivalent to acetaminophen-codeine-caffeine (TYLENOL# 3) for the management of pain after primary elective open septorhinoplasty with osteotomies.

Secondary objectives include comparison of adverse medication effects and complications (e.g., bleeding events and bruising) that occur postoperatively.

Half of the study participants will receive celecoxib, and half will receive acetaminophen-codeine-caffeine.

We hypothesize that both interventions will exhibit no difference in pain control or postoperative bleeding, but that participants taking CELEBREX will experience less medication-related side effects and less bruising postoperatively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Patients 18-80 years old undergoing elective primary open septorhinoplasty withosteotomies by single surgeon, JA.

Exclusion

Exclusion Criteria:

  • • Patients who undergo a rhinoplasty requiring a rib, ear, or temporalis fascia graft (confounding variables for the level of pain experienced)

  • Patients with a known history of chronic pain disorder, or who havegastrointestinal bleeds, peptic ulcer disease or who have other comorbiditiesthat may prevent them from taking NSAIDs such as CELEBREX.

  • Patients with a history of radiation, active head and neck malignancy or otherchronic pain disorders such as various rheumatologic diseases will be excluded todecrease confounding factors in assessing pain.

Study Design

Total Participants: 60
Study Start date:
March 01, 2020
Estimated Completion Date:
December 01, 2020

Study Description

The recent recognition of the opioid crisis has prompted a nationwide search for alternative postoperative analgesia regimens, especially in the field of plastic and reconstructive surgery where patients exhibit a significant risk of persistent opioid use afterward.

As such, the contemporary facial plastics literature has noticed a surge in publications that implement various multi-modal analgesia (MMA) regimens to mitigate narcotic use postoperatively, the results of which seem promising.

Among the opioid-sparing medications utilized in MMA regimens, the selective COX-2 inhibitors (e.g., celecoxib, parecoxib) are of interest given their similar analgesic efficacy and decreased risk profile (less nausea, constipation, and dependence) compared to opioids. Furthermore, selective COX-2 inhibitors avoid adverse gastrointestinal and renal events, as well as the antiplatelet effects associated with conventional NSAIDs (e.g., ibuprofen and naproxen). For these reasons, selective COX-2 inhibitors make for the ideal analgesic to use after facial plastic surgery procedures, where increased bleeding can delay wound healing (e.g., increased bruising and swelling) and cause potentially devastating complications (e.g., hematoma after a facelift, or epistaxis after septorhinoplasty). Nonetheless, studies evaluating the role of selective COX-2 inhibitors as safe and effective alternatives to opioids in plastic surgery are scant.

The primary aim of this study is to evaluate whether celecoxib is equivalent to a routinely prescribed analgesia, acetaminophen-codeine-caffeine (trade name TYLENOL#3) for the management of pain after primary cosmetic open septorhinoplasty with osteotomies. Secondary objectives include comparison of adverse effects that occur post-operatively, with attention to medication side effects, as well as bleeding events and bruising.

We hypothesize that both interventions will exhibit no difference in pain control or postoperative bleeding or bruising, but that participants taking acetaminophen/codeine will experience more adverse effects.

Connect with a study center

  • FACE Toronto

    Toronto, Ontario M4Y 0A2
    Canada

    Active - Recruiting

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