title: Intranasal topical local anesthetic and decongestant for flexible nasendoscopy in children: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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
  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.
authors.affiliation: Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada2Division of Pediatric Otolaryngology-Head and Neck Surgery, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Neil K
authors.initials: NK
authors.lastname: Chadha
authors.affiliation: Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada3currently a medical student at University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Gilbert O A
authors.initials: GO
authors.lastname: Lam
authors.affiliation: Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada2Division of Pediatric Otolaryngology-Head and Neck Surgery, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Ludemann
authors.affiliation: Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada2Division of Pediatric Otolaryngology-Head and Neck Surgery, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Frederick K
authors.initials: FK
authors.lastname: Kozak
mesh_terms: D000281:Administration, Intranasal; D000287:Administration, Topical; D000553:Ambulatory Care; D000772:Anesthesia, Local / Q000379:methods; D000779:Anesthetics, Local / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D019723:Endoscopes; D004724:Endoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage; D008012:Lidocaine / Q000008:administration & dosage; D008297:Male; D009296:Nasal Cavity / Q000187:drug effects; D014663:Nasal Decongestants / Q000008:administration & dosage*; D009668:Nose Diseases / Q000175:diagnosis; D010147:Pain Measurement; D018579:Patient Selection; D011446:Prospective Studies; D012016:Reference Values; D016896:Treatment Outcome
chemical_list: D000779:Anesthetics, Local; D007093:Imidazoles; D014663:Nasal Decongestants; D008012:Lidocaine; C009695:xylometazoline