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

Overview

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.

Full Title of Study: “Celecoxib vs. Acetaminophen-codeine-caffeine for Postoperative Pain in Primary Elective Open Septorhinoplasty With Osteotomies: a Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2020

Detailed 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.

Interventions

  • Drug: Celecoxib 200mg
    • Celecoxib tablet
  • Drug: Acetaminophen, Codeine Drug Combination
    • acetaminophen-codeine-caffeine tablet

Arms, Groups and Cohorts

  • Experimental: Test Arm
    • celecoxib 200 mg tablet by mouth every 12 hours for 7 days postoperatively prn pain
  • Active Comparator: Control Arm
    • codeine 30mg-acetaminophen 300mg-caffeine 15 mg tabelt by mouth every 4 hours for 7 days postoperatively prn pain

Clinical Trial Outcome Measures

Primary Measures

  • Pain Severity
    • Time Frame: until the time of cast removal (up to 8 days postoperatively)
    • Difference in daily mean pain intensity based on Numeric Rating Scale (NRS). The NRS is composed of 0 (no pain at all) to 10 (worst imaginable pain).

Secondary Measures

  • Medication-related side effects
    • Time Frame: for side effects experienced up to the day of cast removal (up to 8 days postoperatively)
    • patient self-reported questionnaire
  • Complications postoperatively
    • Time Frame: for complications experienced up to the day of cast removal (up to 8 days postoperatively)
    • patient self-reported questionnaire
  • Bruising
    • Time Frame: day 6-8. depending on day of cast removal
    • blinded outcome assessor will rank bruising severity based on Numeric Rating Scale (NRS), using postoperative photographs taken on day of cast removal. The NRS is composed of 0 (no brusing at all) to 10 (worst imaginable bruising).

Participating in This Clinical Trial

Inclusion Criteria

  • • Patients 18-80 years old undergoing elective primary open septorhinoplasty with osteotomies by single surgeon, JA. 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 have gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that may prevent them from taking NSAIDs such as CELEBREX. – Patients with a history of radiation, active head and neck malignancy or other chronic pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in assessing pain.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 80 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Blake Raggio
    • Collaborator
      • University of Toronto
    • Provider of Information About this Clinical Study
      • Sponsor-Investigator: Blake Raggio, Clinical Fellow – Humber River Hospital
    • Overall Official(s)
      • Jamil Asaria, MD, Principal Investigator, University of Toronto | FACE Cosmetic Surgery Toronto
    • Overall Contact(s)
      • Blake S Raggio, MD, 504-235-3994, blakeraggio@gmail.com

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