Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

NSAID vs. Narcotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02915055
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

This will be a single-center, prospective observational study. The study will compare post-operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care.

The primary objective of the study is to compare patients' reported pain and narcotic use following meniscectomy, and determine if NSAIDs can provide adequate pain relief.


Condition or disease Intervention/treatment
Multimodal Analgesia Nonsteroidal Anti-inflammatory Drugs Drug: Ibuprofen 600 mg Drug: standard oxycodone/acetaminophen

Layout table for study information
Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multimodal Analgesia With NSAID vs. Narcotics Alone for Post-operative Meniscectomy: A Prospective Observational Study
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen

Group/Cohort Intervention/treatment
Patients with pain following knee arthroscopic meniscectomy Drug: Ibuprofen 600 mg
Ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN

Drug: standard oxycodone/acetaminophen
Other Name: Percocet




Primary Outcome Measures :
  1. Visual analogue scale (VAS) score [ Time Frame: 4 Hours ]
    Scale consisting of a drawn line from 0 to 100 - you will be asked to mark where you believe your pain is (100 being worse pain).

  2. Pain Verbal Rating Scale [ Time Frame: 4 Hours ]
    Verbal rating scale, consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for isolated arthroscopic meniscectomy will be identified from the operating room schedules of orthopaedic surgeons participating in the study. And a review of patients' medications and past medical histories will be performed based on their electronic medical records to identify any current pain medications or exclusion criteria.
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age
  • ASA class I-II
  • Patients scheduled for meniscectomy

Exclusion Criteria:

  • Contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
  • Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age or older than 65
  • Any patient considered a vulnerable subject
  • Patients on pain medication prior to surgery

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): NCT02915055


Locations
Layout table for location information
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Kirk Campbell, MD New York University Medical School

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02915055    
Other Study ID Numbers: 16-01645
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Analgesic efficacy
knee arthroplasty
Opioid consumption
Pain Medicine
Narcotics
Multimodal Analgesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Oxycodone
Narcotics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants