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Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain

13 de agosto de 2019 atualizado por: Defense and Veterans Center for Integrative Pain Management

A Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain

Using a retrospective review of records, we will conduct a multivariate analysis to examine the relationship between exposure to ketamine, as an analgesic agent in combat related trauma care, the use of additional opioid pain medications, and patient reported pain levels.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

This is a retrospective study to determine if there is a relationship between intravenous infusion of ketamine given for analgesia and the use of additional opioid pain medications and patient reported pain levels before and during ketamine usage. The investigator anticipates that records of up to 700 subjects will be reviewed for eligibility. The time period 24 hours before the initial ketamine therapy is initiated along with 24 & 48 hours after the start of ketamine therapy will be the time periods examined. The average/minimum/maximum pain scores during these time periods will be used. Medication usage will be calculated over the 24 hour time periods.

This protocol is presented as an initial step in exploring the possible relationship between the administration of ketamine as an analgesic agent, the potential reduction in pain medications, and the potential reduction of pain levels. With this the goals/objectives are as follows:

Objectives

  1. To compare morphine consumption in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
  2. To compare average/minimum/maximum pain scores in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
  3. To describe the pain trajectory in battlefield injured patients with acute pain after the initiation of ketamine infusions.
  4. To measure the absolute and proportional incidence of ketamine associated side effects in battlefield injured patients with acute pain following the initiation of ketamine infusions.

Tipo de estudo

Observacional

Inscrição (Real)

80

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20889
        • Walter Reed National Military Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Male and female military health care beneficiaries age 18 years and older

Descrição

Inclusion Criteria:

  • Battlefield injured from January 2007 to December 2013
  • Prescribed a ketamine infusion for acute pain
  • Awake, alert (non intubated/sedated), and able to report pain scores 24 hours prior to the start of infusion and up to 48 hours following infusion

Exclusion Criteria:

  • Patients who did not receive an injury in theater and did not receive ketamine while being treated by the APS or WRNMMC/WRAMC hospital staff
  • No continuous perineural catheter or epidural placement while on ketamine infusion
  • Less than 18 years old

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Battlefield Injury with ketamine treatment
Patients who received ketamine infusions to treat pain from January 2007 to December 2013.
Medicamento: cetamina

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Opioid consumption measured in morphine equivalents
Prazo: 24 hours before ketamine infusion
Amount of opioids consumed within time frame
24 hours before ketamine infusion
Opioid consumption measured in morphine equivalents
Prazo: 24 hours after ketamine infusion
Amount of opioids consumed within time frame
24 hours after ketamine infusion
Opioid consumption measured in morphine equivalents
Prazo: 48 hours after ketamine infusion
Amount of opioids consumed within time frame
48 hours after ketamine infusion
Pain scores
Prazo: 24 hours before ketamine infusion

Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale

Rate the severity of your CURRENT pain:

0 - No Pain

  1. - Hardly notice pain
  2. - Notice pain, does not interfere with activities
  3. - Sometimes distracts me
  4. - Distracts me, can do usual activities
  5. - Interrupts some activities
  6. - Hard to ignore, avoid usual activities
  7. - Focus of attention, prevents doing daily activities
  8. - Awful, hard to do anything
  9. - Can't bear pain, unable to do anything
  10. - As bad as it could be, nothing else matters

Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity:

0 - 10 (0=does not interfere, 10=completely interferes)

Circle the number that describes how, during the past 24 hours, pain has interfered with sleep:

0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10
24 hours before ketamine infusion
Pain scores
Prazo: 24 hours after ketamine infusion

Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale

Rate the severity of your CURRENT pain:

0 - No Pain

  1. - Hardly notice pain
  2. - Notice pain, does not interfere with activities
  3. - Sometimes distracts me
  4. - Distracts me, can do usual activities
  5. - Interrupts some activities
  6. - Hard to ignore, avoid usual activities
  7. - Focus of attention, prevents doing daily activities
  8. - Awful, hard to do anything
  9. - Can't bear pain, unable to do anything
  10. - As bad as it could be, nothing else matters

Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity:

0 - 10 (0=does not interfere, 10=completely interferes)

Circle the number that describes how, during the past 24 hours, pain has interfered with sleep:

0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10
24 hours after ketamine infusion
Pain scores
Prazo: 48 hours after ketamine infusion

Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale

Rate the severity of your CURRENT pain:

0 - No Pain

  1. - Hardly notice pain
  2. - Notice pain, does not interfere with activities
  3. - Sometimes distracts me
  4. - Distracts me, can do usual activities
  5. - Interrupts some activities
  6. - Hard to ignore, avoid usual activities
  7. - Focus of attention, prevents doing daily activities
  8. - Awful, hard to do anything
  9. - Can't bear pain, unable to do anything
  10. - As bad as it could be, nothing else matters

Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity:

0 - 10 (0=does not interfere, 10=completely interferes)

Circle the number that describes how, during the past 24 hours, pain has interfered with sleep:

0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10
48 hours after ketamine infusion
Number of ketamine side effects
Prazo: 24 hours before ketamine infusion
Recorded side effects after ketamine infusion
24 hours before ketamine infusion
Number of ketamine side effects
Prazo: 24 after ketamine infusion
Recorded side effects after ketamine infusion
24 after ketamine infusion
Number of ketamine side effects
Prazo: 48 hours after ketamine infusion
Recorded side effects after ketamine infusion
48 hours after ketamine infusion

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Defense and Veterans Center for Integrative Pain Management

Investigadores

  • Investigador principal: Michael Kent, MD, Walter Reed National Military Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2014

Conclusão Primária (Real)

1 de agosto de 2017

Conclusão do estudo (Real)

30 de agosto de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

12 de agosto de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de agosto de 2019

Primeira postagem (Real)

15 de agosto de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de agosto de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de agosto de 2019

Última verificação

1 de agosto de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 399623

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 .

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