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Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized
Sergio Ghirardo1, Matteo Trevisan2, Luca Ronfani3
1Department of Medicine, Surgery and Health Science, University of Trieste, Trieste, Italy. ghirardo.sergio@gmail.com.
Insights
Ibuprofen and ketorolac show similar effectiveness for moderate pain in children with traumatic injuries. For severe pain, ibuprofen demonstrated superior outcomes in reducing pain scores over time.
Area of Science:
- Pediatric Emergency Medicine
- Pain Management
- Pharmacology
Background:
- Acute pain in children following trauma is a common emergency department presentation.
- Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used for pain management in pediatric trauma.
- Limited comparative data exists for ibuprofen versus ketorolac in pediatric acute traumatic pain.
Purpose of the Study:
- To compare the efficacy of oral ibuprofen and ketorolac in managing acute pain in children and adolescents with limb trauma.
- To evaluate pain reduction using the Numeric Rating Scale-11 (NRS-11) at various time points post-administration.
- To assess secondary outcomes including patient-reported pain reduction and achievement of a pain score below 4.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial was conducted in pediatric emergency departments.
- Patients aged 8-17 with limb trauma and moderate (NRS 4-6) or severe (NRS 7-10) pain were enrolled.
- Participants received either ibuprofen (10 mg/kg) or ketorolac (0.5 mg/kg) with matching placebos in a double-dummy design.
Main Results:
- In severe pain, ibuprofen showed a trend towards greater NRS-11 reduction at 60 minutes (2.0 vs 1.0), though not statistically significant (p=0.36).
- Ibuprofen demonstrated significant superiority in secondary outcomes for severe pain at 90 minutes, including lower NRS-11 scores (p=0.008).
- No statistically significant difference in pain reduction was observed between ibuprofen and ketorolac for moderate pain at 60 minutes.
Conclusions:
- Oral ibuprofen and ketorolac are similarly effective for moderate acute traumatic musculoskeletal pain in pediatric patients.
- Ibuprofen may offer advantages over ketorolac for severe acute traumatic pain in children, particularly in achieving sustained pain relief.
- Both medications are viable options for pain management in pediatric trauma, with specific benefits noted for ibuprofen in severe pain scenarios.
Abstract:
This study is to compare ibuprofen and ketorolac for children with trauma-related acute pain. We conducted a multicentre randomized, double-blind, controlled trial in the Paediatric Emergency Department setting. We enrolled patients aged 8 to 17 who accessed the emergency department for pain related to a limb trauma that occurred in the previous 48 h. At the admission, patients were classified based on numeric rating scale-11 (NRS-11) in moderate (NRS 4-6) and severe (NRS 7-10) pain groups. Each patient was randomized to receive either ibuprofen (10 mg/kg) or ketorolac (0.5 mg/kg) and the placebo of the not given drug in a double dummies design. NRS-11 was asked every 30 min until 2 h after drug and placebo administration. The primary outcome was NRS-11 reduction at 60 min. Among 125 patients with severe pain, NRS-11 reduction after 60 min from drug administration was 2.0 (IQR 1.0-4.0) for ibuprofen and 1.0 (IQR 1.0-3.0) for ketorolac (p = 0.36). Ibuprofen was significantly better, considering secondary outcomes, at 90 min with a lower median of NRS-11 (p 0.008), more patients with NRS-11 less than 4 (p 0.01) and a reduction of pain score of more than 3 NRS-11 points (p 0.01). Among 87 patients with moderate pain, the NRS-11 reduction after 60 min from drug administration was 1.63 (± 1.8) for ibuprofen and 1.8 (± 1.6) for ketorolac, with no statistically significant difference.Conclusions: Oral ibuprofen and ketorolac are similarly effective in children and adolescents with acute traumatic musculoskeletal pain.Trial registration: ClinicalTrial.gov registration number: NCT04133623.
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