Evidence map›Paper›PMID 32883371›Full record

Trial reportTrials2020

Non-steroidal or opioid analgesia use for children with musculoskeletal injuries (the No OUCH study): statistical analysis plan.

Anna Heath, Maryna Yaskina, Gareth Hopkin, Terry P Klassen, Christopher McCabe, Martin Offringa, Petros Pechlivanoglou, Juan David Rios, Naveen Poonai, Samina Ali and 1 more

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

Trial report in Trials, 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 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 27% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
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

11 authors at 6 institutions in 2 countries.

Anna HeathChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada. anna.heath@sickkids.ca.ORCID http://orcid.org/0000-0002-7263-4251
Maryna YaskinaWomen and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.
Gareth HopkinInstitute of Health Economics, Edmonton, Alberta, Canada.
Terry P KlassenUniversity of Manitoba, Winnipeg, Manitoba, Canada.
Christopher McCabeInstitute of Health Economics, Edmonton, Alberta, Canada.
Martin OffringaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.
Petros PechlivanoglouInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Juan David RiosChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.
Naveen PoonaiDepartments of Paediatrics, Internal Medicine, Epidemiology & Biostatistics, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada.
Samina AliDepartment of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Canada.
KidsCAN PERC Innovative Pediatric Clinical Trials No OUCH Study Group
Hospital for Sick Children · CAInstitute of Health Economics · CAUniversity of Alberta · CAUniversity of Toronto · CAChildren's Hospital Research Institute of Manitoba · CAWestern University · CA

Funding

Alberta Children's Hospital Research Institute NACentre hospitalier universitaire Sainte-Justine NACHEO Research Institute NAChildren's Hospital Research Institute of Manitoba NACIHR MYG-151207Hospital for Sick Children NAResearch Manitoba NAWestern University NAWomen and Children's Health Research Institute NA
6 · The paper itself

Abstract

backgroundPediatric musculoskeletal injuries cause moderate to severe pain, which should ideally be addressed upon arrival to the emergency department (ED). Despite extensive research in ED-based pediatric pain treatment, recent studies confirm that pain management in this setting remains suboptimal. The No OUCH study consist of two complementary, randomized, placebo-controlled trials that will run simultaneously for patients presenting to the ED with an acute limb injury and a self-reported pain score of at least 5/10, measured via a verbal numerical rating scale (vNRS). Caregiver/parent choice will determine whether patients are randomized to the two-arm or three-arm trial. In the two-arm trial, patients will be randomized to receive either ibuprofen alone or ibuprofen in combination with acetaminophen. In the three-arm trial, patients can also be randomized to a third arm where they would receive ibuprofen in combination with hydromorphone. This article details the statistical analysis plan for the No OUCH study and was submitted before the trial outcomes were available for analysis. METHODS/

designThe primary endpoint of the No OUCH study is self-reported pain at 60 min, recorded using a vNRS. The principal safety outcome is the presence of any adverse event related to study drug administration. Secondary effectiveness endpoints include pain measurements using the Faces Pain Scale-Revised and the visual analog scale, time to effective analgesia, requirement of a rescue analgesic, missed fractures, and observed pain reduction using different definitions of successful analgesia. Secondary safety outcomes include sedation measured using the Ramsay Sedation Score and serious adverse events. Finally, the No OUCH study investigates the reasons given by the caregiver for selecting the two-arm (Non-Opioid) or three-arm (Opioid) trial, caregiver satisfaction, physician preferences for analgesics, and caregiver comfort with at-home pain management. DISCUSSION: The No OUCH study will inform the relative effectiveness of acetaminophen and hydromorphone, in combination with ibuprofen, and ibuprofen alone as analgesic agents for patients presenting to the ED with an acute musculoskeletal injury. The data from these trials will be analyzed in accordance with this statistical analysis plan. This will reduce the risk of producing data-driven results and bias in our reported outcomes.

trial registrationClinicalTrials.gov NCT03767933 . Registered on December 7, 2018.

Indexed as

AnalgesiaAnalgesics, OpioidChildDouble-Blind MethodHumansIbuprofenPainPain ManagementAnalgesics, OpioidIbuprofenAnalgesiaEmergency departmentMusculoskeletal injuryOpioidsPain managementPatient preferenceStatistical analysis plan

Identifiers

PMID32883371
PMCPMC7469310
OpenAlexW3082936453

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.