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Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a
Elena Neri1, Alessandra Maestro, Federico Minen
1Pediatric Emergency Department, Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, Italy.
Insights
Sublingual ketorolac and tramadol offer comparable pain relief for pediatric extremity fractures and dislocations. Both medications effectively reduced pain scores, with no significant differences in efficacy or adverse events between the two treatments.
Area of Science:
- Pediatric Emergency Medicine
- Pain Management
- Pharmacology
Background:
- Effective pain management is crucial for children experiencing fractures or dislocations.
- Sublingual medications offer a non-invasive route for rapid analgesia.
- Comparing novel sublingual formulations like ketorolac and tramadol is important for clinical practice.
Purpose of the Study:
- To evaluate the non-inferiority of sublingual ketorolac compared to sublingual tramadol for acute pain in pediatric extremity fractures/dislocations.
- To assess pain reduction and adverse events in children receiving either sublingual ketorolac or tramadol.
Main Methods:
- A double-blind, randomized, controlled, non-inferiority trial involving 131 children (aged 4-17 years).
- Children received either sublingual ketorolac (0.5 mg/kg) or tramadol (2 mg/kg) using a double-dummy technique.
- Pain was assessed using age-appropriate scales (McGrath, VAS) over 2 hours.
Main Results:
- Both ketorolac and tramadol significantly reduced pain scores within 100 minutes (p<0.001).
- No statistically significant differences in pain reduction were observed between the ketorolac and tramadol groups at any time point.
- Similar frequencies of adverse effects and need for rescue medication (paracetamol-codeine) were noted between groups.
Conclusions:
- Sublingual ketorolac and sublingual tramadol demonstrate equivalent efficacy in managing acute pain associated with pediatric extremity fractures or dislocations.
- Both formulations are well-tolerated, supporting their use in this patient population.
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.