Table 1

Study population (years; FPS, Faces Pain Scale; VAS, visual analogue scale), design (RCT, randomised controlled trial), investigated drugs (sublingual; intranasal), efficacy in pain control at 15–20, 30–40, 60, 90 and 120 min, expressed as FPS/VAS score reduction in millimetres from the baseline pain score (in the study by Le May et al,35 efficacy at 60 min is reported as the percentage of patients achieving a VAS ≤3), adverse events, type and frequency

CitationStudy groupStudy typeOutcomeKey resultComments
Clark et al 29 300 children aged 6–17 years with any baseline pain intensity, due to any injury occurred within the past 48 hours.
Intervention: oral acetaminophen 15 mg/kg versus oral ibuprofen 10 mg/kg versus oral codeine 1 mg/kg.
Double-blind RCTSelf-reported VAS decrease at 60 and 120 minVAS decrease at 60 min: acetaminophen −12, ibuprofen −24, codeine −11, p<0.01.
No difference at 120 min.
Ibuprofen superior to both acetaminophen and codeine in pain control at 60 min after drug administration
Need for rescue analgesiaNo difference
Side effectsNo difference
Koller et al 30 66 children aged 6–18 years with baseline pain ≥4 FPS, due to any injury occurred within the past 24 hours.
Intervention: oral ibuprofen 10 mg/kg versus oral oxycodone 0.1 mg/kg versus oral ibuprofen 10 mg/kg+oxycodone 0.1 mg/kg.
Double-blind RCTSelf-reported FPS decrease at 120 minNo differenceIbuprofen similar to oxycodone and ibuprofen+oxycodone in pain control at 120 min, with lower incidence of minor adverse events
Side effectsIbuprofen 18.2%, oxycodone 4.6%, ibuprofen+oxycodone 42.9%, p=0.036
Friday et al 31 66 children aged 5–17 years with baseline pain ≥5 CAS, due to any isolated extremity injury.
Intervention: oral ibuprofen 10 mg⁄kg versus oral acetaminophen+codeine 1 mg⁄ kg (as codeine).
Double-blind RCTSelf-reported CAS decrease at 20, 40 and 60 minNo differenceIbuprofen similar to acetaminophen+codeine in pain control at 20, 40 and 60 min
Side effectsNo difference
Le May et al 32 81 children aged 6–18 years, with baseline pain ≥4 VAS, due to any extremity injury occurred within the past 72 hours.
Intervention: oral ibuprofen 10 mg⁄kg versus oral ibuprofen 10 mg⁄kg+codeine 1 mg/kg.
Double-blind RCTSelf-reported VAS decrease at 60, 90 and 120 minNo differenceIbuprofen similar to ibuprofen+codeine in pain control at 60, 90 and 120 min
Side effectsNo difference
Neri et al 33 131 children aged 4–17 years, with baseline pain ≥7 VAS, due to any suspected fracture or dislocation.
Intervention: sublingual ketorolac 0.5 mg/kg versus sublingual tramadol 2 mg/kg.
Double-blind RCTSelf-reported VAS decrease at 20, 40, 60 and 120 minNo differenceSublingual ketorolac similar to sublingual tramadol in pain control at 20, 40, 60 and 120 min
Need for rescue analgesiaNo difference
Side effectsNo difference
Poonai et al 34 134 children aged 5–17 years, with any baseline pain intensity, due to any non-operative, extremity fracture sustained within the past 24 hours.
Intervention: oral ibuprofen 10 mg⁄kg versus oral morphine 0.5 mg/kg.
Double-blind RCTSelf-reported FPS-R decrease at 30 minNo differenceOral ibuprofen similar to oral morphine in pain control at 30 min, with less related minor adverse events
Need for rescue analgesiaNo difference
Side effectsIbuprofen 30.9%, morphine 56.1%, p<0.01
Le May et al 35 456 children aged 6–17 years, with baseline pain ≥3 VAS, due to any isolated extremity injury.
Intervention: oral ibuprofen 10 mg/kg versus oral morphine 0.2 mg/kg versus ibuprofen 10 mg/kg+morphine 0.2 mg/kg.
Double-blind RCTSelf-reported VAS decrease at 30, 60 and 90 minNo differenceOral ibuprofen superior to both oral morphine and oral ibuprofen+morphine in pain control at 120 min, with less related minor adverse events
Self-reported VAS decrease at 120 minIbuprofen −27, morphine −16, ibuprofen+morphine −21, p=0.02
Requirement of additional analgesiaNo difference
Side effectsIbuprofen 6.6%, morphine 20.7%, ibuprofen+morphine 21.5%, p<0.001
  • CAS, colour analogue scale; FPS-R, Faces Pain Scale Revised.