Outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain in children and adolescents.


Journal

European journal of pain (London, England)
ISSN: 1532-2149
Titre abrégé: Eur J Pain
Pays: England
ID NLM: 9801774

Informations de publication

Date de publication:
02 2019
Historique:
received: 14 12 2017
revised: 20 08 2018
accepted: 24 08 2018
pubmed: 5 9 2018
medline: 9 5 2019
entrez: 5 9 2018
Statut: ppublish

Résumé

We analysed outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain management in children and adolescents and compared them to the core outcome set recommended by the Pediatric Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (PedIMMPACT). Systematic literature search was conducted in MEDLINE, CDSR, DARE, CINAHL and PsycINFO up to 31 January 2017. One author extracted data and second verified the extraction. Outcome domains and pain outcome measures were analysed and compared with the PedIMMPACT core outcome set. We included 337 trials. Median number of reported outcomes was five (range 1-11) for the included trials and two (range 0-6) for PedIMMPACT. The most commonly analysed PedIMMPACT outcome domains were pain intensity (93%) and "symptoms and adverse events" (83%). The remaining four PedIMMPACT outcomes were present in under 30% of included randomized controlled trials. Proportion of PedIMMPACT outcome domains did not change after the PedIMMPACT was published in 2008. Of the 312 trials that reported pain intensity, 303 (97%) also specified pain assessment tools, in which the most common was the visual analogue scale (24%) followed by the Children's Hospital of Eastern Ontario Pain Scale (18%). Analysed trials about interventions for pediatric postoperative pain insufficiently used the recommended core outcome set for acute pain in children. Relevance of the PedIMMPACT core outcome set, as well as the reasons behind its limited uptake, need to be further evaluated. Recommended core outcomes have been insufficiently used in randomized controlled trials about postoperative pain in children, which hinders comparability of studies and makes synthesis of evidence difficult.

Sections du résumé

BACKGROUND
We analysed outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain management in children and adolescents and compared them to the core outcome set recommended by the Pediatric Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (PedIMMPACT).
METHODS
Systematic literature search was conducted in MEDLINE, CDSR, DARE, CINAHL and PsycINFO up to 31 January 2017. One author extracted data and second verified the extraction. Outcome domains and pain outcome measures were analysed and compared with the PedIMMPACT core outcome set.
RESULTS
We included 337 trials. Median number of reported outcomes was five (range 1-11) for the included trials and two (range 0-6) for PedIMMPACT. The most commonly analysed PedIMMPACT outcome domains were pain intensity (93%) and "symptoms and adverse events" (83%). The remaining four PedIMMPACT outcomes were present in under 30% of included randomized controlled trials. Proportion of PedIMMPACT outcome domains did not change after the PedIMMPACT was published in 2008. Of the 312 trials that reported pain intensity, 303 (97%) also specified pain assessment tools, in which the most common was the visual analogue scale (24%) followed by the Children's Hospital of Eastern Ontario Pain Scale (18%).
CONCLUSION
Analysed trials about interventions for pediatric postoperative pain insufficiently used the recommended core outcome set for acute pain in children. Relevance of the PedIMMPACT core outcome set, as well as the reasons behind its limited uptake, need to be further evaluated.
SIGNIFICANCE
Recommended core outcomes have been insufficiently used in randomized controlled trials about postoperative pain in children, which hinders comparability of studies and makes synthesis of evidence difficult.

Identifiants

pubmed: 30179284
doi: 10.1002/ejp.1313
doi:

Types de publication

Journal Article Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

389-396

Informations de copyright

© 2018 European Pain Federation - EFIC®.

Auteurs

Krste Boric (K)

Department of Traumatology and Orthopaedics, University Hospital Split, Split, Croatia.

Antonia Jelicic Kadic (A)

Department of Pediatrics, University Hospital Split, Split, Croatia.

Matija Boric (M)

Department of Abdominal Surgery, University Hospital Split, Split, Croatia.

Melissa Zarandi-Nowroozi (M)

Laboratory for Pain Research, School of Medicine, University of Split, Split, Croatia.

Dora Jakus (D)

Laboratory for Pain Research, School of Medicine, University of Split, Split, Croatia.

Marija Cavar (M)

Department of Radiology, University Hospital Center Split, Split, Croatia.

Svjetlana Dosenovic (S)

Department of Anesthesiology and Intensive Care, University Hospital Split, Split, Croatia.

Milka Jeric (M)

Department of Dermatovenerology, General Hospital Zadar, Zadar, Croatia.

Marijan Batinic (M)

Laboratory for Pain Research, School of Medicine, University of Split, Split, Croatia.

Igor Vukovic (I)

Department of Anesthesiology and Intensive Care, University Hospital Split, Split, Croatia.

Livia Puljak (L)

Laboratory for Pain Research, School of Medicine, University of Split, Split, Croatia.
Department for Development, Research and Health Technology Assessment, Agency for Medicinal Products and Medical Devices, Zagreb, Croatia.

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