Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
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ClinicalTrials.gov Identifier: NCT03605914 |
Recruitment Status :
Completed
First Posted : July 30, 2018
Last Update Posted : November 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty | Drug: diclofenac Drug: Norco | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty |
Actual Study Start Date : | August 1, 2018 |
Actual Primary Completion Date : | July 1, 2020 |
Actual Study Completion Date : | July 5, 2020 |

Arm | Intervention/treatment |
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Experimental: NSAID
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
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Drug: diclofenac
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. |
Active Comparator: opioid
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).
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Drug: Norco
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 Name: Hydrocodone-Acetaminophen combination medication |
- Pain score as assessed by a 100mm visual analogue scale (VAS) [ Time Frame: 24 hours ]The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
- Pain score as assessed by a 100mm visual analogue scale (VAS) [ Time Frame: 48 hours ]The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
- Pain score as assessed by a 100mm visual analogue scale (VAS) [ Time Frame: 72 hours ]The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
- Pain score as assessed by a 100mm visual analogue scale (VAS) [ Time Frame: 120 hours ]The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
- 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.
- Number of participants with constipation [ Time Frame: 5 days after operation ]
- Number of participants with nausea or vomiting [ Time Frame: 5 days after operation ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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): NCT03605914
United States, Texas | |
The University of Texas Health Science Center at Houston | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Martin Citardi, MD | The University of Texas Health Science Center, Houston |
Responsible Party: | Martin J Citardi, MD, Professor and Chairman, Department of Otorhinolaryngology - Head and Neck Surgery, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT03605914 |
Other Study ID Numbers: |
HSC-MS-18-0242 |
First Posted: | July 30, 2018 Key Record Dates |
Last Update Posted: | November 2, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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.: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Acetaminophen Diclofenac Hydrocodone 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 Narcotics Central Nervous System Depressants Antitussive Agents Respiratory System Agents |