Phase 3
N=185
Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
Outpatient Surgery · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03404518 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Narcotic Usage — 4.9; 2.0 Pills
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Norco (Drug); Ibuprofen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Narcotic Usage |
4.9; 2.0 | — |
| SECONDARY Patient Pain Level |
3.5; 2.8 | — |
| SECONDARY Ibuprofen Usage |
4.5; 7.7 | — |
Summary
Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.
Eligibility Criteria
Inclusion Criteria
Patients undergoing one of the following outpatient procedure:
- Septoplasty
- Unilateral or Bilateral Functional endoscopic sinus surgery
- Tympanomastoidectomy
- Tympanoplasty
- Total or Partial Thyroidectomy
- Parathyroidectomy
- Parotidectomy.
- Age >18 years and 89 years
- Post operative hospital admission
- Allergy to Hydrocodone
- Allergy or contraindication to Ibuprofen or NSAIDs
- Pregnancy
- Hepatic disease
- Chronic kidney disease
- Sickle cell anemia
Data sourced from ClinicalTrials.gov (NCT03404518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.