Pain Management Following Sinus Surgery
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|ClinicalTrials.gov Identifier: NCT03822962|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
This Study evaluates the effect of adding Non-steroidal anti-inflammatories (NSAIDs) to the post-operative pain management of sinus surgery patients and wether or not this addition reduces or eliminates the need for narcotic pain medications.
Patients will be instructed to take an NSAID regimen after surgery and will be instructed to take narcotics only for breakthrough pain.
|Condition or disease||Intervention/treatment||Phase|
|Nasal Sinus; Inflammation Opioid Abuse Pain, Postoperative||Drug: Ibuprofen 600Mg Tablet||Early Phase 1|
National attention has been given to the concerning rise of opioid abuse in this country, with prescriptions for this medications more than quadrupaling in the last 17 years.
Little is known as to the appropriate use of opioid analgesics in the post-operative recovery of patients undergoing sinus surgery. Furthermore, most pain protocols include only Tylenol based opioid analgesics. No study has prospectively evaluated the volume of use of Tylenol based opioid analgesics and whether the addition of NSAIDS decreased the need for opioid analgesics.
This study will compare opioid use with and without the addition of NSAIDS following sinus surgery.
Post-operative opioid use is a great public health concern, relatively unstudied, and an area with an opportunity for potential intervention to significantly reduce risks, morbidity, and mortality to our postoperative patients by better formulating a postoperative pain management plan using evidence-based practices. Appropriate opioid prescribing practices can reduce the risk of addiction, drug overdose, death, and undertreated pain. By optimizing post-operative pain management protocols, the need for opioids following sinus surgery should be minimized.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective, cohort study|
|Masking:||None (Open Label)|
|Official Title:||Post-operative Pain Management Following Functional Endoscopic Sinus Surgery|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2021|
No Intervention: Standard Regimen
Patient will be given a standard regimen:
Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
Active Comparator: Ibuprofen 600mg
Tylenol 1000 mg by mouth every 6 hours scheduled and ibuprofen 600 mg tablet by mouth every 8 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
Drug: Ibuprofen 600Mg Tablet
ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.
- Pain level [ Time Frame: 1 week ]Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication.
- Bleeding episodes [ Time Frame: 1 week ]Any physician visits secondary to bleeding will be tabulated including ER and office visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822962
|Contact: Christie Barnes, MDfirstname.lastname@example.org|
|Contact: Karli Davis, MPHemail@example.com|
|United States, Nebraska|
|The University of Nebraska Medical Center||Not yet recruiting|
|Omaha, Nebraska, United States, 68178|
|Contact: Christie Barnes, MD 402-559-5808 firstname.lastname@example.org|
|Contact: Karli Davis, MPH 402-559-7978 Karli.email@example.com|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267-0528|
|Contact: Lee Zimmer|
|Contact (513) 558-7333 firstname.lastname@example.org|
|Principal Investigator: Christie Barnes, MD|
|Sub-Investigator: Samuel Pate, MD|