A Phase 3 interventional study of Norco and Ibuprofen in Outpatient Surgery and Pain, Postoperative, sponsored by Loma Linda University. Completed at 2 sites in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Loma Linda University · Phase 3, Interventional, and Treatment
Among 10 studies in Pain, Postoperative by Loma Linda University — 2 open to participants now, 2 under way, none of them phase 3. Pain, Postoperative · Loma Linda University.
Among the 10 studies in Pain, Postoperative by Loma Linda University, this one is the only one that started in 2018, is the only one in phase 3, and was the 7th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 185 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →2 of the 10 studies in Pain, Postoperative by Loma Linda University are open now, in 1 country. Each count lists the studies.
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years to 89 Years · all sexes · healthy volunteers too.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2018.
Median enrollment 24 across the 9 interventional studies, 160 across the 1 observational. Of the 5 that completed or were terminated, 3 (60%) have results posted.
Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
1 of the studies in Pain, Postoperative by Loma Linda University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04860141Loma Linda UniversityEfficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction. | 2026-12 |
Among the 10 studies in Pain, Postoperative by Loma Linda University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients undergoing one of the following outpatient procedure:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This 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.
Drug: Norco
This 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.
Drug: Ibuprofen
Drug pages: Hydrocodone · Acetaminophen
Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control
Also known as: Hydrocodone/Acetaminophen, Narcotic
Ibuprofen as first line therapy every 6 hours as needed for pain control
Also known as: NSAID, Motrin, Advil
Narcotic Usage
The average number of narcotic pills needed or used for pain control
Time frame: First 7 days after surgery
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.
Time frame: Average reported pain for first 7 days after surgery
Ibuprofen Usage
The average number of ibuprofen pills needed or used for pain control
Time frame: First 7 days after surgery
| Milestone | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Started | 97 | 88 |
| Completed | 56 | 52 |
| Not completed | 41 | 36 |
| Withdrew: Lost to follow-up | 28 | 30 |
| Withdrew: Protocol violation | 13 | 6 |
The average number of narcotic pills needed or used for pain control
| Pills | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Narcotic Usage | 4.9 (3.6 to 6.3) | 2.0 (0.9 to 3.1) |
The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.
| Scores on a scale | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Patient Pain Level | 3.5 (2.8 to 4.1) | 2.8 (2.2 to 3.4) |
The average number of ibuprofen pills needed or used for pain control
| pills | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Ibuprofen Usage | 4.5 (3.2 to 5.7) | 7.7 (5.8 to 9.6) |
Collected over Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Norco and Ibuprofen | 0/97 (0%) | 0/97 (0%) | 4/97 (4.1%) |
| Ibuprofen and Norco | 0/88 (0%) | 0/88 (0%) | 3/88 (3.4%) |
| Event | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Uncontrolled painSurgical and medical procedures | 1/97 | 2/88 |
| Drainage from surgical siteSurgical and medical procedures | 1/97 | 1/88 |
| HeadacheNervous system disorders | 1/97 | 0/88 |
| NauseaGastrointestinal disorders | 1/97 | 0/88 |
Patients who completed and returned pain data entry
| Age, Continuous(years) | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Mean | 53 ± 17 | 52.9 ± 17 | 53 ± 17 |
| Sex: Female, Male(Participants) | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Female | 37 | 26 | 63 |
| Male | 19 | 26 | 45 |
| Race and Ethnicity Not Collected(Participants) | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Prior Narcotic use(Participants) | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Count of participants | 4 | 3 | 7 |
| Chronic Pain(Participants) | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Count of participants | 15 | 11 | 26 |
| Surgery Length(minutes) | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Mean | 94.4 ± 43 | 95.3 ± 43 | 94.8 ± 42.7 |
| Revision Surgery(Participants) | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Count of participants | 19 | 16 | 35 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Collected data will be analyzed and published. Meaningful data will be available through published material.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Hydrocodone · Acetaminophen