Phase 4
Completed N=65
Postoperative Pain Control in Septum and Sinus Surgery
Post-operative Pain · Sinus Surgery
Source: ClinicalTrials.gov NCT04149964 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Number of Doses of Opiate (Narcotic) Pain Medication — 1.0; 1.5 number of doses
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Doses of Opiate (Narcotic) Pain Medication |
1.0; 1.5 | — |
| SECONDARY Highest Subjective Pain Score |
6.0; 5.0 | — |
| SECONDARY Lowest Subjective Pain Score |
2.0; 2.0 | — |
| SECONDARY Percentage of Time Participant Experienced Severe Pain |
0; 0 | — |
| SECONDARY Participant Use of Acetaminophen as Needed |
12; 2 | — |
| SECONDARY Participant Use of Scheduled Acetaminophen Around the Clock |
3; 11 | — |
| SECONDARY Chronic Use of Pain Medication |
4; 2 | — |
| SECONDARY Participant Use of Additional Pain Medication |
3; 1 | — |
| SECONDARY Types of Other Pain Medication Used |
1; 0; 0; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery
- 18 years of age or older
- Male or female
- No known allergies to or contraindications to the use of acetaminophen, hydrocodone, or oxycodone
- Patients discharged to home after surgery
Exclusion Criteria
- Undergoing revision sinus, septum, or sinus/septum surgery
- Younger than 18 years old
- Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone
- Patients admitted to the hospital postoperatively for airway monitoring
Data sourced from ClinicalTrials.gov (NCT04149964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.