title: Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial.
abstract: OBJECTIVE
  To assess the effectiveness of sublingual ketorolac versus sublingual tramadol in reducing the pain associated with fracture or dislocation of extremities in children.
  
  
  METHODS
  A double-blind, randomised, controlled, non-inferiority trial was conducted in the paediatric emergency department of a research institute. One hundred and thirty-one children aged 4-17 years with suspected bone fracture or dislocation were enrolled. Eligible children were randomised to ketorolac (0.5 mg/kg) and placebo, or to tramadol (2 mg/kg) and placebo by sublingual administration, using a double-dummy technique. Pain was assessed by the patients every 20 min, for a maximum period of 2 h, using the McGrath scale for patients up to 6 years of age, and the Visual Analogue Scale for those older than 6 years of age.
  
  
  RESULTS
  The mean pain scores fell significantly from eight to four and five in the ketorolac and tramadol groups, respectively, by 100 min (Wilcoxon sign rank test, p<0.001). The mean pain scores for ketorolac were lower than those for tramadol, but these differences were not significant at any time point (Mann-Whitney U Test, p values: 0-20 min: 0.167; 20-40 min: 0.314; 40-60 min: 0.223; 60-80 min: 0.348; 80-100 min: 0.166; 100-120 min: 0.08). The rescue dose of paracetamol-codeine was administered in 2/60 children in the ketorolac group versus 8/65 in the tramadol group (Fisher exact test, p=0.098). There were no statistically significant differences between the two groups in the frequency of adverse effects.
  
  
  CONCLUSIONS
  Both sublingual ketorolac and tramadol were equally effective for pain management in children with suspected fractures or dislocations.
authors.affiliation: Pediatric Emergency Department, Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Neri
authors.forename: Alessandra
authors.initials: A
authors.lastname: Maestro
authors.forename: Federico
authors.initials: F
authors.lastname: Minen
authors.forename: Marcella
authors.initials: M
authors.lastname: Montico
authors.forename: Luca
authors.initials: L
authors.lastname: Ronfani
authors.forename: Davide
authors.initials: D
authors.lastname: Zanon
authors.forename: Anna
authors.initials: A
authors.lastname: Favret
authors.forename: Gianni
authors.initials: G
authors.lastname: Messi
authors.forename: Egidio
authors.initials: E
authors.lastname: Barbi
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D005260:Female; D050723:Fractures, Bone / Q000188:drug therapy*; D006801:Humans; D004204:Joint Dislocations / Q000188:drug therapy*; D020910:Ketorolac / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D014147:Tramadol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D014147:Tramadol; D020910:Ketorolac
keywords: Analgesia; General Paediatrics; Pain