Cargando…
Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study
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...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9758024/ https://www.ncbi.nlm.nih.gov/pubmed/36526794 http://dx.doi.org/10.1007/s00431-022-04759-3 |
_version_ | 1784851951494627328 |
---|---|
author | Ghirardo, Sergio Trevisan, Matteo Ronfani, Luca Zanon, Davide Maestro, Alessandra Barbieri, Francesca De Nardi, Laura Amaddeo, Alessandro Barbi, Egidio Cozzi, Giorgio |
author_facet | Ghirardo, Sergio Trevisan, Matteo Ronfani, Luca Zanon, Davide Maestro, Alessandra Barbieri, Francesca De Nardi, Laura Amaddeo, Alessandro Barbi, Egidio Cozzi, Giorgio |
author_sort | Ghirardo, Sergio |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9758024 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-97580242022-12-19 Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study Ghirardo, Sergio Trevisan, Matteo Ronfani, Luca Zanon, Davide Maestro, Alessandra Barbieri, Francesca De Nardi, Laura Amaddeo, Alessandro Barbi, Egidio Cozzi, Giorgio Eur J Pediatr Research 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. Springer Berlin Heidelberg 2022-12-17 2023 /pmc/articles/PMC9758024/ /pubmed/36526794 http://dx.doi.org/10.1007/s00431-022-04759-3 Text en © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2022, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Research Ghirardo, Sergio Trevisan, Matteo Ronfani, Luca Zanon, Davide Maestro, Alessandra Barbieri, Francesca De Nardi, Laura Amaddeo, Alessandro Barbi, Egidio Cozzi, Giorgio Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study |
title | Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study |
title_full | Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study |
title_fullStr | Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study |
title_full_unstemmed | Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study |
title_short | Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study |
title_sort | oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9758024/ https://www.ncbi.nlm.nih.gov/pubmed/36526794 http://dx.doi.org/10.1007/s00431-022-04759-3 |
work_keys_str_mv | AT ghirardosergio oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT trevisanmatteo oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT ronfaniluca oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT zanondavide oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT maestroalessandra oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT barbierifrancesca oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT denardilaura oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT amaddeoalessandro oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT barbiegidio oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy AT cozzigiorgio oralibuprofenversusoralketorolacforchildrenwithmoderateandsevereacutetraumaticpainarandomizedcomparativestudy |