title: A double-blind, randomised, placebo-controlled trial of oral midazolam plus oral ketamine for sedation of children during laceration repair.
abstract: OBJECTIVE
  To compare the efficacy of oral midazolam alone with a combination of oral midazolam and ketamine in children requiring laceration repair.
  
  
  METHODS
  A randomised, double-blind, placebo-controlled study.
  
  
  METHODS
  Paediatric emergency department.
  
  
  METHODS
  Children 1-10 years of age with lacerations requiring sedation.
  
  
  METHODS
  Using a computer-generated sequence, children were randomly assigned in blocks of four to one of two groups: oral midazolam (0.5 mg/kg) plus oral placebo and oral midazolam (0.5 mg/kg) plus oral ketamine (5 mg/kg). The allocation sequence was kept by the pharmacy staff, and the investigators were blinded to randomisation until statistical analysis of the study was completed.
  
  
  METHODS
  Visual Analogue Scale (VAS) assessment by a parent and Sedation Score assessment by an investigator.
  
  
  RESULTS
  60 children were recruited; 29 were assigned for treatment with midazolam and 31 for the combination of midazolam and ketamine. There were no differences in basic demographics and wound characteristics between the groups. VAS assessment by a parent was 4.5±3.3 mm in the midazolam+ketamine group versus 4.4±2.7 mm in the midazolam alone group (mean difference 0.1, CI -1.9 to 1.71). Sedation Score during procedure was lower in the midazolam+ketamine group (mean difference 1.14, 95% CI 0.67 to 1.6). Intravenous sedation was required in two (6%) of the children in the midazolam+ketamine group, and in eight (27%) in the midazolam alone group. p=0.039. No clinically significant adverse effects were documented in either group.
  
  
  CONCLUSIONS
  No difference was found in pain assessment during local anaesthetic injection between the group treated with midazolam and ketamine, and the group treated with midazolam alone. The combination of oral midazolam and ketamine led to deeper sedation than midazolam alone, with less children requiring intravenous sedation.
  
  
  BACKGROUND
  The trial was registered in www.clinicaltrials.gov as NCT01470157.
authors.affiliation: Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel.
authors.forename: Shiri
authors.initials: S
authors.lastname: Barkan
authors.affiliation: Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Rachelle
authors.initials: R
authors.lastname: Breitbart
authors.affiliation: Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel.
authors.forename: Galit
authors.initials: G
authors.lastname: Brenner-Zada
authors.affiliation: Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel.
authors.forename: Michal
authors.initials: M
authors.lastname: Feldon
authors.affiliation: Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel.
authors.forename: Amit
authors.initials: A
authors.lastname: Assa
authors.affiliation: Department of Pharmacy, Assaf Harofeh Medical Center, Zerifin, Israel.
authors.forename: Michal
authors.initials: M
authors.lastname: Toledano
authors.affiliation: Department of Pharmacy, Assaf Harofeh Medical Center, Zerifin, Israel.
authors.forename: Sofia
authors.initials: S
authors.lastname: Berkovitch
authors.affiliation: Department of Pediatric Emergency, Rambam Health Care Campus, Haifa, Israel.
authors.forename: Itai
authors.initials: I
authors.lastname: Shavit
authors.affiliation: Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Eran
authors.initials: E
authors.lastname: Kozer
mesh_terms: D000284:Administration, Oral; D000778:Anesthetics, Dissociative / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D016292:Procedural Sedation / Q000379:methods*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D007223:Infant; D007649:Ketamine / Q000008:administration & dosage*; D022125:Lacerations / Q000601:surgery*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011446:Prospective Studies
chemical_list: D000778:Anesthetics, Dissociative; D006993:Hypnotics and Sedatives; D007649:Ketamine; D008874:Midazolam
keywords: analgesia/pain control; paediatric emergency med; paediatric injury; paediatrics, paediatric emergency medicine; paediatrics, paediatric injury