In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery.

OBJECTIVES/HYPOTHESIS: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting. STUDY DESIGN: Prospective individual cohort study. METHODS: This prospective multicenter study evaluated in-office tube placement in children ages 6 months through 12 years of age. Anesthesia was achieved via lidocaine/epinephrine iontophoresis. Tube placement was conducted using an integrated and automated myringotomy and tube delivery system. Anxiolytics, sedation, and papoose board were not used. Technical success and safety were evaluated. Patients 5 to 12 years old self-reported tube placement pain using the Faces Pain Scale-Revised (FPS-R) instrument, which ranges from 0 (no pain) to 10 (very much pain). RESULTS: Children were enrolled into three cohorts with 68, 47, and 222 children in the Operating Room (OR) Lead-In, Office Lead-In, and Pivotal cohorts, respectively. In the Pivotal cohort, there were 120 and 102 children in the <5 and 5- to 12-year-old age groups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2% of children <5 and 88.2% of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8% (103/120) of children <5 and 89.2% (91/102) of children 5 to 12 years old. Mean FPS-R score was 3.30 (standard deviation [SD] = 3.39) for tube placement and 1.69 (SD = 2.43) at 5 minutes postprocedure. There were no serious adverse events. Nonserious adverse events occurred at rates similar to standard tympanostomy procedures. CONCLUSIONS: In-office tube placement in selected patients can be successfully achieved without requiring sedatives, anxiolytics, or papoose restraints via lidocaine iontophoresis local anesthesia and an automated myringotomy and tube delivery system. LEVEL OF EVIDENCE: 2b Laryngoscope, 130:S1-S9, 2020.

Intranasal topical local anesthetic and decongestant for flexible nasendoscopy in children: a randomized, double-blind, placebo-controlled trial.

IMPORTANCE: To our knowledge, the present study is the first double-blind, randomized, placebo-controlled trial in children to compare nasal preparation sprays administered before flexible nasendoscopy with placebo. OBJECTIVE: To compare the degree of pain experienced by children undergoing flexible nasendoscopy after 1 of 3 intranasal sprays: placebo, decongestant with topical local anesthetic (TLA), or decongestant without TLA. DESIGN, SETTING, AND PARTICIPANTS: A randomized placebo-controlled trial with blinding of participants, caregivers, observers, and otolaryngologists was conducted in a tertiary pediatric otolaryngology ambulatory clinic. Participants included a consecutive sample of children aged 3 to 12 years requiring flexible nasendoscopy. Exclusion criteria included concomitant respiratory tract infection, known allergy to a trial agent, or previous flexible nasendoscopy. One hundred fifty-one children were assessed for eligibility; 24 eligible children refused participation and 69 were included and block-randomized. All completed the study, and there were no adverse events. INTERVENTIONS: Nasal spray administration of placebo (normal saline); xylometazoline hydrochloride, 0.05% (decongestant); or lidocaine hydrochloride, 1%, with xylometazoline hydrochloride, 0.05% (TLA with decongestant) was performed 10 minutes before flexible nasendoscopy. MAIN OUTCOMES AND MEASURES: Primary outcome measure was the child-reported Wong-Baker Faces Pain (WBFP) scale. Secondary outcomes included the caregiver-proxy WBFP scale; the Face, Legs, Activity, Cry, and Consolability (FLACC) scale; and the physician-reported Difficulty of Procedure Visual Analog Scale (DPVAS). RESULTS: Twenty-three children were recruited in each of the intervention arms. Baseline characteristics were comparable between groups. The mean child-rated WBFP scale scores were 2.4, 1.8, and 2.2 for the placebo, decongestant, and TLA with decongestant groups, respectively (P = .45). Although the finding was statistically nonsignificant, decongestant had the lowest mean caregiver-proxy WBFP scale score, lowest observer-rated FLACC scale score, and highest physician-rated DPVAS score. Subgroup analysis did not demonstrate any correlation between the outcomes and age or sex. CONCLUSIONS AND RELEVANCE: This study revealed no statistically significant difference in the discomfort experienced by children undergoing flexible nasendoscopy after placebo, decongestant, or TLA with decongestant. Decongestant was associated with the least discomfort (on child, caregiver, and observer-rated pain scale scores) and the lowest rating for difficulty of procedure. With these findings, the study suggests that there is no significant benefit of topical decongestant with or without TLA compared with placebo in reducing pain associated with pediatric flexible nasendoscopy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01351298.

Manipulation of nasal fractures under local anaesthetic: a convenient method for the Emergency Department and ENT clinic.

BACKGROUND: Nasal fractures are the commonest facial fracture. They can cause morbidity in terms of nasal obstruction and cosmesis. They can be treated by simple external digital manipulation, provided they are seen and assessed in a timely fashion. This manipulation is commonly done under general anaesthetic (GA), which utilises precious resources and may cause delays in treatment. SUMMARY OF EVIDENCE FOR PROPOSED METHOD: A recent comprehensive systematic review has shown local anaesthetic (LA) to be comparable to GA in terms of cosmesis, airway patency and patient acceptability. The experience for the patient is akin to that of a dental filling, and can be made more painless with the use of topical anaesthesia. PROPOSED METHOD: In the current age of evidence-based medicine and drive for cost-effective management decisions, it is thought that LA manipulation may offer a superior option to GA. A simple method for manipulation under LA is presented that can be done in the Emergency Department.

Local anaesthesia for manipulation of nasal fractures: systematic review.

OBJECTIVE: To determine the most effective local anaesthetic method for manipulation of nasal fractures, and to compare the efficacy of local anaesthesia with that of general anaesthesia. METHOD: Systematic review and meta-analysis. DATABASES: Medline, Embase, Cochrane Library, National Research Register and metaRegister of Controlled Trials. INCLUDED STUDIES: We included randomised, controlled trials comparing general anaesthesia with local anaesthesia or comparing different local anaesthetic techniques. Non-randomised studies were also systematically reviewed and appraised. No language restrictions were applied. RESULTS: Five randomised, controlled trials were included, three comparing general anaesthesia versus local anaesthesia and two comparing different local anaesthetic methods. No significant differences were found between local anaesthesia and general anaesthesia as regards pain, cosmesis or nasal patency. The least painful local anaesthetic method was topical tetracaine gel applied to the nasal dorsum together with topical intranasal cocaine solution. Minimal adverse events were reported with local anaesthesia. CONCLUSIONS: Local anaesthesia appears to be a safe and effective alternative to general anaesthesia for pain relief during nasal fracture manipulation, with no evidence of inferior outcomes. The least uncomfortable local anaesthetic method included topical tetracaine gel.