NSAID vs. Narcotics

NCT02915055 | Completed FDA Drug

• 1 other identifier: 16-01645
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Multimodal Analgesia; Nonsteroidal Anti-inflammatory Drugs

Keywords

Analgesic efficacy; knee arthroplasty; Opioid consumption; Pain Medicine; Narcotics; Multimodal Analgesia

Outcome Measures

Primary Outcomes (2)

• Visual analogue scale (VAS) score

  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).

  4 Hours

• Pain Verbal Rating Scale

  Verbal rating scale, consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe).

  4 Hours

Study Arms (1)

Patients with pain following knee arthroscopic meniscectomy

Drug: Ibuprofen 600 mg; Drug: standard oxycodone/acetaminophen

Interventions

Ibuprofen 600 mg DRUG

Ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN

Patients with pain following knee arthroscopic meniscectomy

standard oxycodone/acetaminophen DRUG

Also known as: Percocet

Patients with pain following knee arthroscopic meniscectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Ibuprofen; Acetaminophen; oxycodone-acetaminophen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Kirk Campbell, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

US (1)