Cargando…

Adaptive randomised controlled non-inferiority multicentre trial (the Ketodex Trial) on intranasal dexmedetomidine plus ketamine for procedural sedation in children: study protocol

INTRODUCTION: Up to 40% of orthopaedic injuries in children require a closed reduction, almost always necessitating procedural sedation. Intravenous ketamine is the most commonly used sedative agent. However, intravenous insertion is painful and can be technically difficult in children. We hypothesi...

Descripción completa

Detalles Bibliográficos
Autores principales:	Poonai, Naveen, Coriolano, Kamary, Klassen, Terry, Heath, Anna, Yaskina, Maryna, Beer, Darcy, Sawyer, Scott, Bhatt, Maala, Kam, April, Doan, Quynh, Sabhaney, Vikram, Offringa, Martin, Pechlivanoglou, Petros, Hickes, Serena, Ali, Samina
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2020
Materias:	Paediatrics
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7733175/ https://www.ncbi.nlm.nih.gov/pubmed/33303457 http://dx.doi.org/10.1136/bmjopen-2020-041319

Ejemplares similares

The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan
por: Heath, Anna, et al.
Publicado: (2021)

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)
por: Ali, Samina, et al.
Publicado: (2020)

Non-steroidal or opioid analgesia use for children with musculoskeletal injuries (the No OUCH study): statistical analysis plan
por: Heath, Anna, et al.
Publicado: (2020)

Innovative approaches to investigator-initiated, multicentre paediatric clinical trials in Canada
por: Kelly, Lauren E, et al.
Publicado: (2019)

A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences
por: Ali, Samina, et al.
Publicado: (2021)

Correction to: A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences
por: Ali, Samina, et al.
Publicado: (2021)

Determining a Bayesian predictive power stopping rule for futility in a non-inferiority trial with binary outcomes
por: Heath, Anna, et al.
Publicado: (2020)

‘NOPAIN-ROP’ trial: Intravenous fentanyl and intravenous ketamine for pain relief during laser photocoagulation for retinopathy of prematurity (ROP) in preterm infants: A randomised trial
por: Madathil, Shamnad, et al.
Publicado: (2021)

External cold and vibration for pain management of children undergoing needle-related procedures in the emergency department: a randomised controlled non-inferiority trial protocol
por: Ballard, Ariane, et al.
Publicado: (2019)

Intranasal ketamine for procedural sedation and analgesia in children: A systematic review
por: Poonai, Naveen, et al.
Publicado: (2017)

The design of a multicentre Canadian surveillance study of sedation safety in the paediatric emergency department
por: Bhatt, Maala, et al.
Publicado: (2015)

Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children
por: Ali, Samina, et al.
Publicado: (2018)

Virtual reality-based distraction for intravenous insertion-related distress in children: a study protocol for a randomised controlled trial
por: Ali, Samina, et al.
Publicado: (2022)

Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity
por: Orkin, Julia, et al.
Publicado: (2019)

Safety of corticosteroids in young children with acute respiratory conditions: a systematic review and meta-analysis
por: Fernandes, Ricardo M, et al.
Publicado: (2019)

Randomised placebo-controlled multicentre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community-acquired pneumonia: a trial protocol for the KIDS-STEP trial
por: Kohns Vasconcelos, Malte, et al.
Publicado: (2020)

Nordic study on human milk fortification in extremely preterm infants: a randomised controlled trial—the N-forte trial
por: Jensen, Georg Bach, et al.
Publicado: (2021)

COllaborative Neonatal Network for the first European CPAM Trial (CONNECT): a study protocol for a randomised controlled trial
por: Kersten, Casper M, et al.
Publicado: (2023)

Publication bias in pediatric emergence delirium: a cross-sectional analysis of ClinicalTrials.gov and ClinicalTrialsRegister.eu
por: Meyburg, Jochen, et al.
Publicado: (2020)

PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research
por: Kapadia, Mufiza Z, et al.
Publicado: (2016)

The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): a protocol for a randomised controlled trial
por: Beker, Friederike, et al.
Publicado: (2019)

A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol
por: Hodgson, Kate A, et al.
Publicado: (2020)

Caffeine prophylaxis to improve intermittent hypoxaemia in infants born late preterm: a randomised controlled dosage trial (Latte Dosage Trial)
por: Oliphant, Elizabeth Anne, et al.
Publicado: (2020)

The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial
por: Neubert, Antje, et al.
Publicado: (2017)

Melatonin for sleep disorders in children with neurodevelopmental disorders: protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials
por: Jørgensen, Caroline Kamp, et al.
Publicado: (2022)

Providing Oxygen during Intubation in the NICU Trial (POINT): study protocol for a randomised controlled trial in the neonatal intensive care unit in the USA
por: Herrick, Heidi M, et al.
Publicado: (2023)

Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial
por: Matsuyama, Nao, et al.
Publicado: (2022)

Treating Parents to Reduce NICU Transmission of Staphylococcus aureus (TREAT PARENTS) trial: protocol of a multisite randomised, double-blind, placebo-controlled trial
por: Milstone, Aaron M, et al.
Publicado: (2015)

The QuickWee trial: protocol for a randomised controlled trial of gentle suprapubic cutaneous stimulation to hasten non-invasive urine collection from infants
por: Kaufman, Jonathan, et al.
Publicado: (2016)

The NICE-GUT trial protocol: a randomised, placebo controlled trial of oral nitazoxanide for the empiric treatment of acute gastroenteritis among Australian Aboriginal children
por: Waddington, Claire S, et al.
Publicado: (2018)

Protocol for the Lactoferrin Infant Feeding Trial (LIFT): a randomised trial of adding lactoferrin to the feeds of very-low birthweight babies prior to hospital discharge
por: Martin, Andrew, et al.
Publicado: (2018)

Pediatric Adenotonsillectomy Trial for Snoring (PATS): protocol for a randomised controlled trial to evaluate the effect of adenotonsillectomy in treating mild obstructive sleep-disordered breathing
por: Wang, Rui, et al.
Publicado: (2020)

Early PARacetamol (EPAR) trial: a study protocol for a randomised controlled trial of early paracetamol to promote closure of the ductus arteriosus in preterm infants
por: Schindler, Tim, et al.
Publicado: (2019)

Pharmacokinetic research in children: an analysis of registered records of clinical trials
por: Viergever, Roderik F, et al.
Publicado: (2011)

Global shortage of neonatal and paediatric antibiotic trials: rapid review
por: Thompson, Georgina, et al.
Publicado: (2017)

Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol
por: Samuel, Susan, et al.
Publicado: (2019)

Ketodex for MRI sedation in syndromic children with congenital cardiac anomalies – A case series
por: Magoon, Rohan, et al.
Publicado: (2022)

‘Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing’ (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention
por: Opel, Douglas J, et al.
Publicado: (2020)

The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital diaphragmatic hernia
por: Cochius-den Otter, Suzan, et al.
Publicado: (2019)

Multicentre, randomised trial of preterm infants receiving caffeine and less invasive surfactant administration compared with caffeine and early continuous positive airway pressure (CaLI trial): study protocol
por: Ines, Felix, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_4dv5udc5aso5aichc5885igtkf