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Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department

INTRODUCTION: Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility o...

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Autores principales: Reynolds, Stacy L, Studnek, Jonathan R, Bryant, Kathleen, VanderHave, Kelly, Grossman, Eric, Moore, Charity G, Young, James, Hogg, Melanie, Runyon, Michael S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020878/
https://www.ncbi.nlm.nih.gov/pubmed/27609854
http://dx.doi.org/10.1136/bmjopen-2016-012190
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author Reynolds, Stacy L
Studnek, Jonathan R
Bryant, Kathleen
VanderHave, Kelly
Grossman, Eric
Moore, Charity G
Young, James
Hogg, Melanie
Runyon, Michael S
author_facet Reynolds, Stacy L
Studnek, Jonathan R
Bryant, Kathleen
VanderHave, Kelly
Grossman, Eric
Moore, Charity G
Young, James
Hogg, Melanie
Runyon, Michael S
author_sort Reynolds, Stacy L
collection PubMed
description INTRODUCTION: Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage. METHODS AND ANALYSIS: This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4–17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug. ETHICS AND DISSEMINATION: This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial. TRIAL REGISTRATION NUMBER: NCT02521415.
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spelling pubmed-50208782016-09-20 Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department Reynolds, Stacy L Studnek, Jonathan R Bryant, Kathleen VanderHave, Kelly Grossman, Eric Moore, Charity G Young, James Hogg, Melanie Runyon, Michael S BMJ Open Emergency Medicine INTRODUCTION: Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage. METHODS AND ANALYSIS: This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4–17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug. ETHICS AND DISSEMINATION: This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial. TRIAL REGISTRATION NUMBER: NCT02521415. BMJ Publishing Group 2016-09-08 /pmc/articles/PMC5020878/ /pubmed/27609854 http://dx.doi.org/10.1136/bmjopen-2016-012190 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Emergency Medicine
Reynolds, Stacy L
Studnek, Jonathan R
Bryant, Kathleen
VanderHave, Kelly
Grossman, Eric
Moore, Charity G
Young, James
Hogg, Melanie
Runyon, Michael S
Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department
title Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department
title_full Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department
title_fullStr Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department
title_full_unstemmed Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department
title_short Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department
title_sort study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department
topic Emergency Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020878/
https://www.ncbi.nlm.nih.gov/pubmed/27609854
http://dx.doi.org/10.1136/bmjopen-2016-012190
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