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.
BMJ Open
; 6(9): e012190, 2016 09 08.
Article
em En
| MEDLINE
| ID: mdl-27609854
ABSTRACT
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 ANDANALYSIS:
This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1â mg/kg) to IN fentanyl (1.5â µg/kg) for analgesia in 80 children aged 4-17â 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 60â min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20â 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Dor
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Projetos de Pesquisa
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Fentanila
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Serviço Hospitalar de Emergência
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Fraturas Ósseas
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Ketamina
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Guideline
Limite:
Adolescent
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Child
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Child, preschool
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Female
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Humans
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Male
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Estados Unidos