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Trial record 12 of 158 for:    bleeding episodes | ( Map: United States )

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
Sponsor:
Information provided by (Responsible Party):
Christie Barnes, University of Nebraska

Brief Summary:

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Bleeding episodes [ Time Frame: 1 week ]
    Any physician visits secondary to bleeding will be tabulated including ER and office visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction).

Exclusion Criteria:

Anti-coagulation medications including aspirin Aspirin-exacerbated respiratory disease Cystic Fibrosis Primary Ciliary Dyskinesia Inclusion of a Draf III frontal sinusotomy Liver/Kidney Failure Thrombocytopenia Poorly controlled hypertension Recent GI ulcers or gastritis Chronic pain as defined by a narcotic prescription with 6 months or involvement in a pain management program Primary Headache disorder The use of nasal decongestants in the post-operative period. The use of nasal packing or absorbable biomaterials.


Information from the National Library of Medicine

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


Contacts
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Contact: Christie Barnes, MD 4025595808 christie.barnes@unmc.edu
Contact: Karli Davis, MPH 402-559-7978 karli.burt@unmc.edu

Locations
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United States, Nebraska
The University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68178
Contact: Christie Barnes, MD    402-559-5808    christie.barnes@unmc.edu   
Contact: Karli Davis, MPH    402-559-7978    Karli.burt@unmc.edu   
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0528
Contact: Lee Zimmer         
Contact    (513) 558-7333    zimmerli@ucmail.uc.edu   
Principal Investigator: Christie Barnes, MD         
Sub-Investigator: Samuel Pate, MD         
Sponsors and Collaborators
University of Nebraska

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Responsible Party: Christie Barnes, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03822962     History of Changes
Other Study ID Numbers: 417-18
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Christie Barnes, University of Nebraska:
NSAIDs
post-operative pain
post-operative hemorrhage
Functional endoscopic sinus surgery
Additional relevant MeSH terms:
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Sinusitis
Inflammation
Pain, Postoperative
Opioid-Related Disorders
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action