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AzTrials

Outpatient SurgeryPhase 3NCT03404518

Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

A Phase 3 study testing Norco and Ibuprofen in people with Outpatient Surgery and Pain, Postoperative, run by Loma Linda University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home. Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Outpatient Surgery, Pain, Postoperative
What is being tested?
Norco and Ibuprofen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
2 sitesUnited States
Study dates
21 Feb 2018to 1 Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing one of the following outpatient procedure:
  • Septoplasty
  • Unilateral or Bilateral Functional endoscopic sinus surgery
  • Tympanomastoidectomy
  • Tympanoplasty
  • Total or Partial Thyroidectomy
Show all 9Show fewer
  • Parathyroidectomy
  • Parotidectomy.
  • Age >18 years and < 89 years

Who cannot join

  • Age < 18 years or > 89 years
  • Post operative hospital admission
  • Allergy to Hydrocodone
  • Allergy or contraindication to Ibuprofen or NSAIDs
  • Pregnancy
  • Hepatic disease
  • Chronic kidney disease
  • Sickle cell anemia

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Loma Linda University Surgical Hospital

    Loma Linda, California, 92354

Other trials in United States

About this study

Official title: Quantifying Narcotic Use in Outpatient Otolaryngology Procedures

Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.

Read the detailed description

It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe.

The objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.

Patients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed.

Being tested
Norco, Ibuprofen
Keywords
Thyroidectomy, Parotidectomy, Tympanoplasty, Mastoidectomy, Septoplasty, Sinus Surgery, Postoperative pain, Outpatient surgery
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NorcoDrug

    Also called Hydrocodone/Acetaminophen, Narcotic

    Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control

  • IbuprofenDrug

    Also called NSAID, Motrin, Advil

    Ibuprofen as first line therapy every 6 hours as needed for pain control

Study groups in NCT03404518
Study groupRoleWhat they receive
Norco and IbuprofenExperimentalThis group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.
Receives: Drug: Norco
Ibuprofen and NorcoActive comparatorThis group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.
Receives: Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Narcotic Usage

    The average number of narcotic pills needed or used for pain control

    Measured: First 7 days after surgery

Secondary outcomes (2)

  1. Patient Pain Level

    The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.

    Measured: Average reported pain for first 7 days after surgery

  2. Ibuprofen Usage

    The average number of ibuprofen pills needed or used for pain control

    Measured: First 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2018
  2. Study start21 Feb 2018
  3. Primary completion1 Oct 2018
  4. Study completion1 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03404518
Sponsor's protocol ID
5170252
Status last verified
Feb 2022
First submitted
11 Jan 2018
Last updated
16 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Collected data will be analyzed and published. Meaningful data will be available through published material.

Publications

  • Sommer M, Geurts JW, Stessel B, Kessels AG, Peters ML, Patijn J, van Kleef M, Kremer B, Marcus MA. Prevalence and predictors of postoperative pain after ear, nose, and throat surgery. Arch Otolaryngol Head Neck Surg. 2009 Feb;135(2):124-30. doi: 10.1001/archoto.2009.3.

    PubMed 19221238

  • Foghsgaard S, Foghsgaard J, Homoe P. Early post-operative morbidity after superficial parotidectomy: a prospective study concerning pain and resumption of normal activity. Clin Otolaryngol. 2007 Feb;32(1):54-7. doi: 10.1111/j.1365-2273.2007.01315.x.

    PubMed 17298314

  • Song CM, Ji YB, Bang HS, Kim KR, Kim H, Tae K. Postoperative Pain After Robotic Thyroidectomy by a Gasless Unilateral Axillo-Breast or Axillary Approach. Surg Laparosc Endosc Percutan Tech. 2015 Dec;25(6):478-82. doi: 10.1097/SLE.0000000000000204.

    PubMed 26422088

  • van Dijk JF, Kappen TH, Schuurmans MJ, van Wijck AJ. The Relation Between Patients' NRS Pain Scores and Their Desire for Additional Opioids after Surgery. Pain Pract. 2015 Sep;15(7):604-9. doi: 10.1111/papr.12217. Epub 2014 Apr 16.

    PubMed 24735082

  • van Dijk JF, van Wijck AJ, Kappen TH, Peelen LM, Kalkman CJ, Schuurmans MJ. Postoperative pain assessment based on numeric ratings is not the same for patients and professionals: a cross-sectional study. Int J Nurs Stud. 2012 Jan;49(1):65-71. doi: 10.1016/j.ijnurstu.2011.07.009. Epub 2011 Aug 15.

    PubMed 21840522

  • Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.

    PubMed 21724620

  • Ossiander EM. Using textual cause-of-death data to study drug poisoning deaths. Am J Epidemiol. 2014 Apr 1;179(7):884-94. doi: 10.1093/aje/kwt333. Epub 2014 Feb 11.

    PubMed 24521559

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Norco and Ibuprofen in people with Outpatient Surgery and Pain, Postoperative, run by Loma Linda University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Narcotic Usage (time frame: First 7 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03404518, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

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