Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery
Brief Summary: Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).

This prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI).

The results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.


Options:
A: Inclusion Criteria:

* Pregnant women with a gestational age of 63 days or less
* Desire a medical abortion with mifepristone and misoprostol

Exclusion Criteria:

- Have contraindications to ibuprofen
B: Inclusion Criteria:

* 18 years or older
* English-speaking
* Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS)
* Can commit to follow up for at least one postoperative visit

Exclusion Criteria:

Patients undergoing a septorhinoplasty (septoplasty permissible if patient will also undergo sinus surgery)

* Doyle splints to be used
* Alcohol or opioid use disorder
* History of chronic pain disorders
* Regular use of acetaminophen/NSAIDS (\>4x per week)
* Patients who use narcotics or neuromodulating drugs (e.g. gabapentin, nortriptyline)more than 2x per week on average.
* Gastrointestinal ulcers or bleeding
* Chronic kidney disease/known decreased renal function (estimated glomerular filtration rate \<60)
* Liver cirrhosis or other hepatic impairment
* Prior adverse reaction to opioids or NSAIDS
* Other contraindications to any drug classes in either group.
C: Inclusion criteria:

* Males and females 18 to 55 years of age;
* Outpatients scheduled to undergo surgical extraction of 3-4 impacted third molar(s), with a minimum of two mandibular extractions. The two mandibular third molars may be partial bony impactions or full bony impactions (as long as the trauma rating is not severe and the surgeons do not feel the subject will have extreme post-surgical pain) OR there may be a combination of one full bony impaction with the second mandibular being a soft tissue impaction or partial bony impaction. Maxillary third molars (or supernumerary teeth) of any type can be extracted;
* Use of only the following preoperative medication(s)/ anesthetic(s): topical benzocaine, short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide;
* Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form;
* Examined by the attending oral surgeon or physician and medically cleared to participate in the study;
* Scheduled to undergo a qualifying surgical procedure;
* In good general health, with a BMI of 30 or less, and have no contraindications to any of the study medications or anesthetic drugs;
* Subjects have at least a categorical pain score of moderate and a numerical rating scale (NRS) score of 5 or greater within 4.5 hours from the time of the last suture.

Exclusion criteria:

* Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, hyper- or hypothyroidism);
* Use of a prescription or non-prescription drug with which the administration of ibuprofen or any other non steroidal anti inflammatory or caffeine is contraindicated;
* Acute local infection at the time of surgery that could confound the post-surgical evaluation;
* Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, intravaginal or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test;
* Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic ulcer disease;
* History of alcoholism or substance abuse within the last year, or is currently abusing alcohol or other mood-altering drugs (e.g., cannabis). Subjects who are taking central nervous system or other psychotropic drugs (including St. Johns Wort, or any other nutritional supplement known to have psychotropic effects) may be enrolled if they have been on stable doses of medication for at least 2 months, will maintain this dose throughout the study, and their condition is judged by the Principal Investigator to be well-controlled;
* Habituation to analgesic drugs or caffeine (i.e., routine use of oral analgesics 5 or more times per week or ingestion of 4 or more caffeine-containing drinks daily); use of "high energy" drinks more than once per week;
* Use of any type of systemic corticosteroid within the past 30 days or a history of current or previous use of anabolic steroids;
* History of allergic reaction (e.g., asthma, rhinitis, swelling, shock, or hives) to acetaminophen, ibuprofen, naproxen, aspirin, celecoxib, or any other non steroidal anti inflammatory or caffeine;
* Prior use of any type of analgesic or non steroidal anti inflammatory within 5 half-lives of that drug before surgery, except for pre-anesthetic medication and anesthesia for the procedure;
* Ingestion of any caffeine-containing beverages, chocolate, or alcohol 6 hours or less before surgery;
* Has impaired liver function, e.g., serum Alanine transaminase, aspartate aminotransferase, alkaline phosphatase, or Gamma-glutamyltransferase greater than 2.5 times the upper limit of normal, or blood urea nitrogen, creatinine, or bilirubin greater than 1.5 times the upper limit of normal without a known benign explanation;
* Has known history of a positive HIV antibody test or known HIV infection;
* Has a known history of Hepatitis B or C;
* Has a clinically significant abnormal electrocardiogram (ECG) at screening as determined by the Investigator:
* Has taken an investigational product within the past 30 days;
* Has previously been entered into this study;
* The subject is a member of the study site staff either directly involved with the study, an employee of the Sponsor, or a relative of study site personnel directly involved with the study or Sponsor.
D: Inclusion Criteria:

* diagnosed with OSAS,
* scheduled for tonsillectomy plus/minus adenoid removal at MUMC,
* between the ages of 1-10years

Exclusion Criteria:

* contraindications to analgesia,
* asthma,
* has had previous adenotonsillectomy, or
* any craniofacial,
* neuromuscular or cardiac conditions

Answer: B