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OpenTrials
Completed

NCT Number: NCT03605914

Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.

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Key information

Conditions

Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • english speaking
  • candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
  • scheduled for surgery at Texas Sinus Institute

Exclusion criteria

  • allergy to either NSAIDs or opioids
  • contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
  • surgical plan exceeding basic endoscopic sinus surgery
  • use of anticoagulation
  • the presence of any pain disorder
  • the current usage of any analgesic medication
  • history of opioid addiction
  • pregnancy
  • history of chronic pain or fibromyalgia
  • current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)

Treatment and study plan

Diclofenac

Drug

The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.

Norco

Drug

The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).

Other names: Hydrocodone-Acetaminophen combination medication

Primary outcomes

  1. Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

    Time frame: 24 hours (day 1 after operation)

    The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

Secondary outcomes

  1. Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

    Time frame: 48 hours (day 2 after operation)

    The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

  2. Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

    Time frame: 72 hours (day 3 after operation)

    The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

  3. Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

    Time frame: 120 hours (day 5 after operation)

    The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

  4. Number of Participants With Bleeding Complications

    Time frame: 5 days after operation

    Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.

  5. Number of Participants With Constipation

    Time frame: 5 days after operation

  6. Number of Participants With Nausea or Vomiting

    Time frame: 5 days after operation

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2018
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.