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| Name | Class |
|---|---|
| University of Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Arm | Experimental | celecoxib 200 mg tablet by mouth every 12 hours for 7 days postoperatively prn pain |
|
| Control Arm | Active Comparator | codeine 30mg-acetaminophen 300mg-caffeine 15 mg tabelt by mouth every 4 hours for 7 days postoperatively prn pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib 200mg | Drug | Celecoxib tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity | 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). | until the time of cast removal (up to 8 days postoperatively) |
| Measure | Description | Time Frame |
|---|---|---|
| Medication-related side effects | patient self-reported questionnaire | for side effects experienced up to the day of cast removal (up to 8 days postoperatively) |
| Complications postoperatively | patient self-reported questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
• Patients who undergo a rhinoplasty requiring a rib, ear, or temporalis fascia graft (confounding variables for the level of pain experienced)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blake S Raggio, MD | Contact | 504-235-3994 | blakeraggio@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jamil Asaria, MD | University of Toronto | FACE Cosmetic Surgery Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FACE Toronto | Recruiting | Toronto | Ontario | M4Y 0A2 | Canada |
De-identified individual participant data for all primary and secondary outcome measures will be made available
Data will be available within 6 months of study completion
Data access requests will be reviewed by an external Independent Review Panel. Requests will be required to sign a Data Access Agreement
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2020 | Feb 4, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| C526278 | acetaminophen, codeine drug combination |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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The surgeon (Care provider) performing all of the septorhinoplasty procedures will be blinded as to which pain medication the patients will receive postoperatively.
The outcomes assessor evaluating the severity of bruising (using postoperative photographs taken on day of cast removal) will be blinded as to which pain medication the patient received
| Acetaminophen, Codeine Drug Combination | Drug | acetaminophen-codeine-caffeine tablet |
|
|
| for complications experienced up to the day of cast removal (up to 8 days postoperatively) |
| Bruising | 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). | day 6-8. depending on day of cast removal |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D000588 | Amines |