Gabapentin and postoperative pain and opioid consumption: A double-blind randomized controlled trial of perioperative pain management for sinus surgery.

BACKGROUND: The link between post-operative narcotic prescription and opioid misuse has spurred a nationwide effort to reduce perioperative opioid use. Previous work has suggested that perioperative gabapentin may reduce post-operative pain and opioid consumption across different procedures, although the optimal regimen remains to be defined. METHODS: Chronic rhinosinusitis (CRS) patients undergoing functional endoscopic sinus surgery (FESS) with or without septoplasty were randomized to receive a 7-day pre- and post-operative course of placebo or gabapentin, starting at 300 mg daily and titrated to 300 mg three times daily, in a double-blind fashion. Primary endpoint was pain level using a validated visual analog scale (VAS). Secondary endpoints included post-operative opioid consumption and side effects, as well as modified Lund-Kennedy endoscopy, Lund-Mackay, and SNOT-22 scores. RESULTS: Analysis of 35 patients (20 gabapentin, 15 control) showed no significant difference in mean postoperative VAS (p = 0.18) or postoperative opioid consumption between the placebo and gabapentin groups (2.3 and 4.8 oxycodone tablets respectively, p = 0.18). 15 of 35 patients did not require any post-operative oxycodone tablets, and only two patients required more than six tablets. CONCLUSION: Preliminary results show no significant change in pain after FESS with or without septoplasty in patients taking 7-day pre- and post-operative gabapentin versus placebo. Results also showed no significant difference in opioid consumption between the treatment and placebo groups. Post-operative pain scores and opioid requirements are both quite low following FESS. Many patients do not need opioids at all, suggesting that routine initial post-operative opioid prescriptions can be limited accordingly.

Omega-3 Fatty Acid Supplementation for the Treatment of Persistent COVID-Related Olfactory Dysfunction.

OBJECTIVE: To evaluate the efficacy of omega-3 fatty acid (O3FA) supplementation in the treatment of COVID-related olfactory dysfunction (OD). METHODS: Patients with laboratory-confirmed or clinically-suspected COVID-19 infection and new-onset OD from August 2020 to November 2021 were prospectively recruited. Patients with quantitative OD, defined as a brief smell identification test (BSIT) score of 9 or less, were eligible for study inclusion. The experimental group received 2 g of O3FA supplementation, while the control group received an identical placebo to be taken daily for 6 weeks. The primary outcome was a change in BSIT score between the initial and 6-week follow-up tests. RESULTS: One hundred and seventeen patients were included in the analysis, including 57 patients in the O3FA group and 60 in the placebo group. O3FA group patients demonstrated a mean BSIT improvement of 1.12 ± 1.99 compared to 0.68 ± 1.86 in the placebo group (p = 0.221). Seventy-seven patients, 42 within the O3FA group and 35 in the placebo group, completed a follow-up BSIT survey at an average of 717.8 days from study onset. At long-term follow-up, there was an average BSIT score improvement of 1.72 within the O3FA group compared to 1.76 within the placebo group (p = 0.948). CONCLUSION: Among patients with persistent COVID-related OD, our study showed no clear evidence of relative short-term or long-term olfactory recovery among patients receiving high doses of O3FA supplementation.

Seeking an optimal dose of preoperative corticosteroids in chronic rhinosinusitis with nasal polyposis: A randomized controlled trial.

BACKGROUND: Preoperative corticosteroids have been shown to improve surgical visibility and intraoperative blood loss for chronic rhinosinusitis with nasal polyposis (CRSwNP) patients undergoing endoscopic sinus surgery (ESS). However, there is no consensus on the optimal dosing regimen. METHODS: A randomized, controlled trial was conducted to compare low, medium, and high dose corticosteroids prior to ESS. Patients with CRSwNP refractory to medical management were randomized to low (N = 8), medium (N = 10), or high (N = 5) dosing regimens of corticosteroids prior to ESS. Baseline disease severity was measured with the 22-item Sino-nasal Outcome Test and Lund-Mackay scores. Modified Lund-Kennedy endoscopic scores (MLKES) were measured at baseline and after corticosteroid treatment. Intraoperative parameters were measured including Boezaart surgical visibility score, intraoperative blood loss, and operative time. RESULTS: Medium dose corticosteroids demonstrated a superior surgical visibility score to low dose and comparable results to high dose, but these results were not significant (p = 0.33). No significant difference was observed between groups for total blood loss (p = 0.15), operative time (p = 0.87), or change in MLKES (p = 0.27). CONCLUSIONS: Current recommendations include the use of preoperative corticosteroids in patients with CRSwNP undergoing ESS, but there is no consensus on dose or duration. We did not find a statistically significant difference in surgical field visibility, intraoperative blood loss, or operative time between different dosing regimens. Further studies are needed to evaluate the efficacy of a low-dose preoperative regimen with the goal of reducing cumulative patient exposure to systemic corticosteroids.

Long Term Olfactory Outcomes Following Frontal Sinus Surgery in Chronic Rhinosinusitis.

OBJECTIVES/HYPOTHESIS: No studies have evaluated the impact of the types of frontal sinus surgery (FSS) on objective olfaction scores. This study evaluated olfactory function and quality of life (QOL) in chronic rhinosinusitis (CRS) patients before and after total ethmoidectomy with frontal sinusotomy (FS). STUDY DESIGN: Prospective cohort study. METHODS: A prospective study of adult CRS patients undergoing FSS (Draf 2 or Draf 3 procedures) was conducted at a tertiary care center. Primary outcomes included brief smell identification test (BSIT) and sinonasal outcome test-22 (SNOT-22), which were assessed during preoperative evaluation, 6 to 9 weeks postoperatively, and 12 to 24 weeks postoperatively. Normosmia was defined as BSIT ≥9. Statistical significance was determined using the Wilcoxon signed-rank test with α = .05. RESULTS: Thirty-eight patients followed up 12 to 24 weeks after FSS. The differences between baseline and long-term outcomes for BSIT (6.11 vs. 8.24, P = .00034) and SNOT-22 (55.49 vs. 24.32, P < .00001) scores were found to be statistically significant. Although both subgroups had clinically significant olfactory improvements, only the Draf 2 cohort experienced a statistically significant improvement in olfaction at long-term follow-up. There was no statistically significant change in data from 6 to 9 weeks to 12 to 24 weeks postoperatively. CONCLUSIONS: Patients undergoing total ethmoidectomy with FS demonstrated statistically significant increases in olfaction and QOL at long-term postoperative follow-up. This study demonstrated that FS does not negatively impact the olfactory improvement seen in sinus surgery. The lack of statistically significant changes in these olfactory metrics from short to long-term follow-up suggests that there is no additional negative effect of FSS in the long term. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:2173-2178, 2021.

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series.

BACKGROUND: 68 Gallium-DOTATATE (68 Ga-DOTATATE) is a somatostatin analog used as a PET tracer to successfully identify neuroendocrine tumors (NETs). Due to the rarity of sinonasal NETs, there are few recommendations for 68 Ga-DOTATATE imaging in these patients. METHODS: We discussed the impact of 68 Ga-DOTATATE imaging on the management of six sinonasal NET cases and reviewed existing literature. RESULTS: 68 Ga-DOTATATE PET/CT revealed an unknown primary in one case and identified metastatic disease in a primary sinonasal small cell neuroendocrine carcinoma (SNEC) patient missed on conventional imaging. In two esthesioneuroblastoma (ENB) patients, 68 Ga-DOTATATE detected abnormal radiotracer uptake not present on 18F-FDG PET/CT and identified a patient for treatment with 177 Lu-DOTATATE. CONCLUSIONS: This is the one of the first few reports, and the largest series to our knowledge, demonstrating the utility of 68 Ga-DOTATATE imaging for primary sinonasal SNEC and ENB. Further study is required to determine its role in sinonasal NET management.

Enhancing Patient Experience in Office-Based Laryngology Procedures With Passive Virtual Reality.

OBJECTIVES: Virtual reality (VR) has been used as nonpharmacologic anxiolysis benefiting patients undergoing office-based procedures. There is little research on VR use in laryngology. This study aims to determine the efficacy of VR as anxiolysis for patients undergoing in-office laryngotracheal procedures. STUDY DESIGN: Randomized controlled trial. SETTING: Tertiary care center. METHODS: Adult patients undergoing office-based larynx and trachea injections, biopsy, or laser ablation were recruited and randomized to receive standard care with local anesthesia only or local anesthesia with adjunctive VR. Primary end point was procedural anxiety measured by the Subjective Units of Distress Scale (SUDS). Subjective pain, measured using a visual analog scale, satisfaction scores, and procedure time, and baseline anxiety, measured using the Hospital Anxiety and Depression Scale (HADS), were also collected. RESULTS: Eight patients were randomized to the control group and 8 to the VR group. SUDS scores were lower in the VR group than in the control group with mean values of 26.25 and 53.13, respectively (P = .037). Baseline HADS scores did not differ between groups. There were no statistically significant differences in pain, satisfaction, or procedure time. Average satisfaction scores in VR and control groups were 6.44 and 6.25, respectively (P = .770). Average pain scores were 3.53 and 2.64, respectively (P = .434). CONCLUSION: This pilot study suggests that VR distraction may be used as an adjunctive measure to decrease patient anxiety during office-based laryngology procedures. Procedures performed using standard local anesthesia resulted in low pain scores and high satisfaction scores even without adjunctive VR analgesia. LEVEL OF EVIDENCE: 1.

Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures.

OBJECTIVES/HYPOTHESIS: While virtual reality (VR) has been used as analgesia and anxiolysis for invasive procedures, no literature exists on the use of VR in the pediatric otolaryngology setting. The purpose of this study was to determine the efficacy of VR in reducing pain and anxiety for pediatric otolaryngology patients. STUDY DESIGN: Randomized controlled trial. METHODS: A total of 53 patients aged 7-17 undergoing in-office nasal endoscopies were included. Patients were randomized to receive VR or standard of care. Procedural pain, anxiety, and satisfaction scores were recorded from patients and caregivers. The physician filled out a childhood emotional manifestation scale (CEMS). RESULTS: Patients in VR group reported a significant decrease in pain (0.80 ± 1.06 vs. 2.26 ± 2.38, P = .018) and anxiety (9.50 ± 12.48 vs. 38.48 ± 29.83, P = .0002) and increase in procedural satisfaction (6.40 ± 0.77 vs. 4.74 ± 1.74, P = .0002) compared to patients in control group. CEMS scores were significantly reduced in VR group (5.15 ± 0.46 vs. 9.64 ± 5.66, P = .0001) and caregiver anxiety levels were significantly reduced in VR group (11.50 ± 17.67 vs. 27.39 ± 30.48, P = .041) compared to control group. There were no reported side effects. Procedural time did not significantly differ between groups. CONCLUSIONS: For pediatric otolaryngology patients undergoing in-office nasal endoscopies, VR is a safe and effective form of distraction analgesia and anxiolysis, significantly reducing pain and increasing procedural satisfaction for patients. In addition, VR significantly reduces anxiety for both patients and caregivers without disrupting procedural efficiency and workflow. LEVEL OF EVIDENCE: 2. Laryngoscope, 131:E1714-E1721, 2021.

Letter to the editor: Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction.

OBJECTIVES: To evaluate a therapeutic role for omega-3 fatty acid supplementation in the treatment of olfactory dysfunction associated with COVID-19 infection TRIAL DESIGN: Randomized, double-blinded, placebo-controlled trial PARTICIPANTS: Eligible patients are adults with self-reported new-onset olfactory dysfunction of any duration associated with laboratory-confirmed or clinically suspected COVID-19 patients. Exclusion criteria include patients with pre-existing olfactory dysfunction, history of chronic rhinosinusitis or history of sinus surgery, current use of nasal steroid sprays or omega-3 supplementation, fish allergy, or inability to provide informed consent for any reason. The trial is conducted at Mount Sinai Hospital INTERVENTION AND COMPARATOR: The intervention group will receive 2000 mg daily of omega-3 supplementation in the form of two "Fish Oil, Ultra Omega-3" capsules (product of Pharmavite®) daily. The comparator group will take 2 placebo capsules of identical size, shape, and odor daily for 6 weeks. MAIN OUTCOMES: Each subject will take a Brief Smell Identification Test at study enrolment and completion after 6 weeks. The primary outcome will be change in Brief Smell Identification Test over the 6-week period. RANDOMISATION: Patients will be randomized by the Investigational Drug Pharmacy at the Icahn School of Medicine at Sinai via a computer-generated sequence in a 1:1 allocation to treatment or control arms. BLINDING (MASKING): Both participants and researchers will be blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): There will be 88 participants randomized to each group. A total of 176 participants will be randomized. TRIAL STATUS: Protocol Version 1, 8/3/2020 Recruitment is ongoing, started 8/5/2020 with estimated completion 11/30/2020. TRIAL REGISTRATION: The trial is registered on ClinicalTrials.gov with Protocol Identifier: NCT04495816 . TRIAL REGISTRATION: ClinicalTrials.gov, NCT04495816 . Registered 3 August 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).