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Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

NCT ID: NCT03457116

Last Updated: 2021-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2020-11-02

Brief Summary

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The purpose of this study is to compare the efficacy and safety of oral opiate pain medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative rhinoplasty pain. This study will also evaluate potential contributing factors affecting the efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used for post-operative pain. The study will then compare which is more effective in controlling post operative pain.

Detailed Description

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Conditions

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Rhinoplasty Non-steroidal Ant Inflammatory Drugs Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NSAIDS

400mg of Ibuprofen

Group Type ACTIVE_COMPARATOR

NSAID

Intervention Type DRUG

Ibuprofen 400mg for post-operative pain

Opiates

Norco (hydrocodone 5mg- acetaminophen 325mg)

Group Type ACTIVE_COMPARATOR

Norco

Intervention Type DRUG

20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)

Interventions

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Norco

20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)

Intervention Type DRUG

NSAID

Ibuprofen 400mg for post-operative pain

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Exclusion Criteria

* Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
* Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
* Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
* Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judy Lee, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

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NYU Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17-01839

Identifier Type: -

Identifier Source: org_study_id