title: Utility of intranasal Ketamine and Midazolam to perform gastric aspirates in children: a double-blind, placebo controlled, randomized study.
abstract: BACKGROUND
  We performed a prospective, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam (INKM) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis.
  
  
  METHODS
  evaluation of Modified Objective Pain Score (MOPS) reduction in children undergoing INKM compared to the placebo group.
  
  
  RESULTS
  evaluation of safety of INKM protocol, start time sedation effect, duration of sedation and evaluation of parents and doctors' satisfaction about the procedure.
  
  
  METHODS
  In the sedation group, 19 children, mean age 41.5 months, received intranasal Midazolam (0.5 mg/kg) and Ketamine (2 mg/kg). In the placebo group, 17 children received normal saline solution twice in each nostril. The child's degree of sedation was scored using the MOPS. A questionnaire was designed to evaluate the parents' and doctors' opinions on the procedures of both groups.
  
  
  RESULTS
  Fifty-seven gastric washings were performed in the sedation-group, while in the placebo-group we performed 51 gastric aspirates. The degree of sedation achieved by INMK enabled all procedures to be completed without additional drugs. The mean duration of sedation was 71.5 min. Mean MOPS was 3.5 (range 1-8) in the sedation-group, 7.2 (range 4-9) in the placebo-group (p <0.0001). The questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group. The only side effect registered was post-sedation agitation in 6 procedures in the sedation group (10.5%).
  
  
  CONCLUSIONS
  Our experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children.
  
  
  BACKGROUND
  Unique trial Number: UMIN000010623; Receipt Number: R000012422.
authors.affiliation: Department of Pediatric Sciences, Catholic University of Rome, Largo A, Gemelli, 1, 00168 Rome, Italy. danilobuonsenso@gmail.com.
authors.forename: Danilo
authors.initials: D
authors.lastname: Buonsenso
authors.forename: Giovanni
authors.initials: G
authors.lastname: Barone
authors.forename: Piero
authors.initials: P
authors.lastname: Valentini
authors.forename: Filomena
authors.initials: F
authors.lastname: Pierri
authors.forename: Riccardo
authors.initials: R
authors.lastname: Riccardi
authors.forename: Antonio
authors.initials: A
authors.lastname: Chiaretti
mesh_terms: D000281:Administration, Intranasal / Q000295:instrumentation; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D002675:Child, Preschool; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D005766:Gastrointestinal Contents; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects; D007649:Ketamine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008874:Midazolam / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D011446:Prospective Studies; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*
chemical_list: D000700:Analgesics; D006993:Hypnotics and Sedatives; D007649:Ketamine; D008874:Midazolam