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Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial
  1. Elena Neri1,
  2. Alessandra Maestro2,
  3. Federico Minen3,
  4. Marcella Montico4,
  5. Luca Ronfani4,
  6. Davide Zanon2,
  7. Anna Favret3,
  8. Gianni Messi1,
  9. Egidio Barbi1
  1. 1Pediatric Emergency Department, Institute for Maternal and Child Health—IRCCS “Burlo Garofolo”, Trieste, Italy
  2. 2Clinical Services of Pharmacy, Institute for Maternal and Child Health—IRCCS “Burlo Garofolo”, Trieste, Italy
  3. 3University of Trieste, Trieste, Italy
  4. 4Epidemiology and Biostatistics Unit, Institute for Maternal and Child Health—IRCCS “Burlo Garofolo”, Trieste, Italy
  1. Correspondence to Dr Federico Minen, University of Trieste, Trieste, 34100, Italy; federicominen{at}gmail.com

Abstract

Objectives To assess the effectiveness of sublingual ketorolac versus sublingual tramadol in reducing the pain associated with fracture or dislocation of extremities in children.

Patients and 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.

  • Analgesia
  • General Paediatrics
  • Pain

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