Evidence map›Paper›PMID 32565458›Full record

ArticleBMJ open2020

Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study).

Samina Ali, Manasi Rajagopal, Terry Klassen, Lawrence Richer, Christopher McCabe, Andy Willan, Maryna Yaskina, Anna Heath, Amy L Drendel, Martin Offringa and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03767933 (A Study of Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.6field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03767933 phase2completednot on this map

A Study of Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries: The No OUCH Trials

TypeinterventionalSponsorUniversity of AlbertaRan2019 to 2023Enrolled710ConditionsMusculoskeletal InjuryArmsIbuprofen, Acetaminophen, Hydromorphone, Acetaminophen placebo, Hydromorphone placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 2 countries.

Samina AliPediatrics, University of Alberta, Edmonton, Alberta, Canada sali@ualberta.ca.ORCID 0000-0002-0595-364X
Manasi RajagopalPediatrics, University of Alberta, Edmonton, Alberta, Canada.
Terry KlassenChildren's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.
Lawrence RicherPediatrics, University of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0002-6897-8668
Christopher McCabeEmergency Medicine, University of Alberta, Edmonton, Alberta, Canada.
Andy WillanDalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
Maryna YaskinaWomen and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.
Anna HeathDalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
Amy L DrendelPediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Martin OffringaChild Health Evaluation Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.
Serge GouinPediatrics, Universite de Montreal, Montreal, Québec, Canada.
Antonia StangPediatrics, University of Calgary, Calgary, Alberta, Canada.
Scott SawyerPediatrics and Emergency Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
Maala BhattPediatrics, University of Ottawa, Ottawa, Ontario, Canada.
Serena HickesParent Partner, Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.
Naveen PoonaiPaediatrics and Internal Medicine, Schulich School of Medicine & Dentistry, London Health Sciences Centre, London, Ontario, Canada.
KidsCAN PERC Innovative Pediatric Clinical Trials No OUCH Study Team
University of Alberta · CAChildren's Hospital Research Institute of Manitoba · CAUniversity of Toronto · CAHospital for Sick Children · CALondon Health Sciences Centre · CAMedical College of Wisconsin · USUniversité de Montréal · CAUniversity of Calgary · CAUniversity of Manitoba · CAUniversity of Ottawa · CA

Funding

CIHR MYG-151207
6 · The paper itself

Abstract

introductionMusculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children's pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference. METHODS AND ANALYSIS: Using a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019. ETHICS AND DISSEMINATION: This study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant. TRIAL REGISTRATION NUMBER: NCT03767933, first registered on 07 December 2018.

Indexed as

Equivalence Trials as TopicAcetaminophenAdolescentAnalgesics, Non-NarcoticAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalCanadaChildEmergency Service, HospitalExtremitiesHumansHydromorphoneIbuprofenMulticenter Studies as TopicMusculoskeletal PainPain ManagementAcetaminophenAnalgesics, Non-NarcoticAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalHydromorphoneIbuprofenaccident & emergency medicinepaediatric orthopaedicspain management

Identifiers

PMID32565458
PMCPMC7311068
OpenAlexW3036069312

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.