title: A randomized clinical trial comparing oral, aerosolized intranasal, and aerosolized buccal midazolam.
abstract: OBJECTIVE
  We determine whether aerosolized intranasal or buccal midazolam reduces the distress of pediatric laceration repair compared with oral midazolam.
  
  
  METHODS
  Children aged 0.5 to 7 years and needing nonparenteral sedation for laceration repair were randomized to receive oral, aerosolized intranasal, or aerosolized buccal midazolam. Patient distress was rated by blinded review of videotapes, using the Children's Hospital of Eastern Ontario Pain Score. Secondary outcomes included activity scores, sedation adequacy, sedation onset, satisfaction, and adverse events.
  
  
  RESULTS
  For the 169 subjects (median age 3.1 years) evaluated for the primary outcome, we found significantly less distress in the buccal midazolam group compared with the oral route group (P=.04; difference -2; 95% confidence interval -4 to 0) and a corresponding nonsignificant trend for the intranasal route (P=.08; difference -1; 95% confidence interval -3 to 1). Secondary outcomes (177 subjects) favored the intranasal group, including a greater proportion of patients with an optimal activity score (74%), a greater proportion of parents wanting this sedation in the future, and faster sedation onset. Intranasal was the route least tolerated at administration. Adverse events were similar between groups.
  
  
  CONCLUSIONS
  When comparing the administration of midazolam by 3 routes to facilitate pediatric laceration repair, we observed slightly less distress in the aerosolized buccal group. The intranasal route demonstrated a greater proportion of patients with optimal activity scores, greater proportions of parents wanting similar sedation in the future, and faster onset but was also the most poorly tolerated at administration. Aerosolized buccal or intranasal midazolam represents an effective and useful alternative to oral midazolam for sedation for laceration repair.
authors.affiliation: Seattle Children's Hospital, Seattle, WA, USA. eileen.klein@seattlechildrens.org
authors.forename: Eileen J
authors.initials: EJ
authors.lastname: Klein
authors.forename: Julie C
authors.initials: JC
authors.lastname: Brown
authors.forename: Ana
authors.initials: A
authors.lastname: Kobayashi
authors.forename: Daniel
authors.initials: D
authors.lastname: Osincup
authors.forename: Kristy
authors.initials: K
authors.lastname: Seidel
mesh_terms: D000278:Administration, Buccal; D000281:Administration, Intranasal; D000284:Administration, Oral; D000336:Aerosols; D002648:Child; D002675:Child, Preschool; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000627:therapeutic use; D007223:Infant; D022125:Lacerations / Q000628:therapy; D008297:Male; D008874:Midazolam / Q000008:administration & dosage* / Q000627:therapeutic use; D010290:Parents; D017060:Patient Satisfaction; D013315:Stress, Psychological / Q000517:prevention & control
chemical_list: D000336:Aerosols; D006993:Hypnotics and Sedatives; D008874:Midazolam