Determining if the Buzzy® Personal Pain Relief Device Reduces Injection Pain of Propofol as Much as Intravenous Lidocaine in Children
A Randomized Comparison of the Buzzy® Personal Pain Relief Device to Intravenous Lidocaine for Controlling Injection Pain During Intravenous Propofol Induction of Anesthesia in Children
Propofol is a drug commonly used for induction of general anesthesia in children as well as adults; however, propofol can cause pain on injection, possibly more frequently in children. One common method of preventing propofol injection pain is the injection of lidocaine just prior to the injection of propofol through an intravenous catheter. This practice is sometimes, but not universally, effective, and involves exposure of patients to an additional drug. Our proposal is to use a non-pharmacologic adjunct in an attempt to attenuate the pain of propofol injection. The Buzzy® personal pain relief device is an FDA-approved product that provides non-pharmacologic relief of pain from minor painful procedures in children. The investigators propose the non-invasive Buzzy® personal pain relief device might prove just as effective at relieving the pain of propofol injection as the injection of intravenous lidocaine just prior to propofol injection. Randomized groups and a blinded observer will be used in this study of 106 children, with one group of patients receiving a current standard of care for reduction of the pain of propofol injection, that is, lidocaine prior to propofol, and one group receiving the placement of the Buzzy® device above the injection site prior to injection of propofol to reduce the pain of propofol injection.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients who are in the American Society of Anesthesiologists with physical status classification I to III (meaning healthy patients, patients with mild systemic disease, and patients with serious controlled systemic disease)
- Between the ages of 12 and 17
- Presenting from home for procedures including, but not limited to, upper and lower endoscopy, orthopedic surgery, and medical imaging.
Exclusion Criteria:
- Patients requiring a rapid sequence induction of anesthesia and patients requiring an emergency procedure
- Patients requiring mask induction for anesthesia
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Buzzy device
Use of the Buzzy device during propofol induction in an attempt to alleviate propofol injection pain |
Outros nomes:
|
|
Comparador Ativo: Intravenous lidocaine
Use of intravenous lidocaine during propofol induction in an attempt to alleviate propofol injection pain |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Non-inferiority of Buzzy pain relief device as compared to intravenous lidocaine at preventing pain on injection of propofol
Prazo: Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
|
Two scales will be used by the observer to rate the amount of pain, if any, on propofol injection, the FLACC (face, legs, activity, cry, consolability) Scale and the Cameron Four Point Scale for Pain on Propofol Injection. The FLACC Scale is a 0-10 scale where the observer rates pain based on facial expression, movement of the body and legs, vocalization, and reassurability. The Cameron Scale was developed by researchers to specifically rate the pain of propofol injection for a previous study, and uses the presence or absence of grimace, cry, and withdrawal to rate pain on a 0-3 scale. Both scales are being used because the FLACC Scale was not specifically designed for propofol pain, and has some limitations in its application for this purpose; however, the Cameron Scale is limited by its narrow application of three types of expressions of pain. |
Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Vital Signs
Prazo: Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
|
The heart rate and blood pressure will be recorded just prior to induction of anesthesia, when 25% of the induction dose of propofol has been given, and every minute after induction of anesthesia for eight minutes. Heart rate and blood pressure variations will serve as a secondary indicator of pain on propofol injection. |
Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Buzzy for propofol pain relief
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .