NCT04259333

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

Celecoxib vs. Acetaminophen-codeine-caffeine for Postoperative Pain in Primary Elective Open Septorhinoplasty With Osteotomies: a Randomized Controlled Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Blake Raggio · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pain, Postoperative
• Surgery--Complications
• Opioid Analgesic Adverse Reaction
• Opioid Use

Interventions

Type	Name	Description
DRUG	Celecoxib 200mg	Celecoxib tablet
DRUG	Acetaminophen, Codeine Drug Combination	acetaminophen-codeine-caffeine tablet

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-02-06
• Last updated: 2020-08-04

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study