Evidence map›Paper›PMID 33407719›Full record

Trial reportTrials2021

The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan.

Anna Heath, Juan David Rios, Eleanor Pullenayegum, Petros Pechlivanoglou, Martin Offringa, Maryna Yaskina, Rick Watts, Shana Rimmer, Terry P Klassen, Kamary Coriolano and 2 more

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

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04195256 (Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 38% 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.

NCT04195256 phase2 / phase3recruitingnot on this map

Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children: an Adaptive Randomized Controlled Non-inferiority Multicenter Trial

TypeinterventionalSponsorNaveen PoonaiRan2020 to 2026Enrolled400ConditionsFracture, DislocationArmsIN Ketodex (D4K2), IN Ketodex (D3K3), IN Ketodex (D2K4), IV Ketamine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

12 authors at 5 institutions in 2 countries.

Anna HeathChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada. anna.heath@sickkids.ca.ORCID http://orcid.org/0000-0002-7263-4251
Juan David RiosChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.
Eleanor PullenayegumChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.
Petros PechlivanoglouChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.
Martin OffringaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.
Maryna YaskinaWomen & Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.
Rick WattsWomen & Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.
Shana RimmerWomen & Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.
Terry P KlassenUniversity of Manitoba, Winnipeg, Manitoba, Canada.
Kamary CoriolanoLondon Health Sciences Centre, Children's Hospital, London, Ontario, Canada.
Naveen PoonaiDepartments of Paediatrics and Epidemiology & Biostatistics, Schulich School of Medicine and Dentistry, London, Canada.
PERC-KIDSCAN Ketodex Study Group
University of Alberta · CAUniversity of Toronto · CAWestern University · CALondon Health Sciences Centre · CARoyal Statistical Society · GB

Funding

Academic Medical Organization of Southwestern Ontario NAAlberta Children's Hospital Research Institute NACentre hospitalier universitaire Sainte-Justine NAChildren's Health Foundation of the Children's Hospital, London Health Sciences Foundation NAChildren's Hospital of Eastern Ontario Research Institute NAChildren's Hospital Research Institute of Manitoba NACIHR MYG-151207Hospital for Sick Children NA, Ontario Ministry of Economic Development, Job Creation and Trade NAPhysicians' Services Incorporated Foundation NAThe Governors of the University of Alberta NAWestern University NAWomen and Children's Health Research Institute NA
6 · The paper itself

Abstract

backgroundProcedural sedation and analgesia (PSA) is frequently required to perform closed reductions for fractures and dislocations in children. Intravenous (IV) ketamine is the most commonly used sedative agent for closed reductions. However, as children find IV insertion a distressing and painful procedure, there is need to identify a feasible alternative route of administration. There is evidence that a combination of dexmedetomidine and ketamine (ketodex), administered intranasally (IN), could provide adequate sedation for closed reductions while avoiding the need for IV insertion. However, there is uncertainty about the optimal combination dose for the two agents and whether it can provide adequate sedation for closed reductions. The Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation (Ketodex) study is a Bayesian phase II/III, non-inferiority trial in children undergoing PSA for closed reductions that aims to address both these research questions. This article presents in detail the statistical analysis plan for the Ketodex trial and was submitted before the outcomes of the trial were available for analysis. METHODS/

designThe Ketodex trial is a multicenter, four-armed, randomized, double-dummy controlled, Bayesian response adaptive dose finding, non-inferiority, phase II/III trial designed to determine (i) whether IN ketodex is non-inferior to IV ketamine for adequate sedation in children undergoing a closed reduction of a fracture or dislocation in a pediatric emergency department and (ii) the combination dose for IN ketodex that provides optimal sedation. Adequate sedation will be primarily measured using the Pediatric Sedation State Scale. As secondary outcomes, the Ketodex trial will compare the length of stay in the emergency department, time to wakening, and adverse events between study arms. DISCUSSION: The Ketodex trial will provide evidence on the optimal dose for, and effectiveness of, IN ketodex as an alternative to IV ketamine providing sedation for patients undergoing a closed reduction. The data from the Ketodex trial will be analyzed from a Bayesian perspective according to this statistical analysis plan. This will reduce the risk of producing data-driven results introducing bias in our reported outcomes.

trial registrationClinicalTrials.gov NCT04195256 . Registered on December 11, 2019.

Indexed as

DexmedetomidineKetamineAdministration, IntranasalAnalgesicsBayes TheoremChildHumansHypnotics and SedativesAnalgesicsDexmedetomidineHypnotics and SedativesKetamineBayesian adaptive designIntranasal ketodexNon-inferiority trialPediatric closed reductionProcedural sedation and analgesiaStatistical analysis plan

Identifiers

PMID33407719
PMCPMC7789159
OpenAlexW3120128204

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.