- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07670507
Pilot Randomized Control Trial Comparing Oral Ketamine and Oral Oxycodone for Pain Control in Emergency Department Patients (PKORCT)
The goal of this pilot randomized clinical trial is to learn if oral ketamine intervention can control pain in emergency department patients whose providers feel the need for additional pain medication. The main questions it aims to answer are:
- Does oral ketamine result in a different mean change in pain scores compared with oral oxycodone?
- Is there a difference in the need for additional opioid administration within 24 hours after the initial dose of study medication (oral ketamine vs oral oxycodone)?
Researchers will compare oral ketamine to oral oxycodone to see if there is a difference in pain control or the need for additional opioid administration.
Participants will:
- Fill out a survey prior to study medication administration assessing pain scores, pain presentation, and medication history
- Be randomized to and receive a dose of oral ketamine or oral oxycodone as the study medication for pain control
- Fill out a survey assessing pain control, side effects, and safety outcomes
- Receive follow-up phone calls at 1 and 3 months after enrollment to assess pain and opioid use
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
In an effort to combat the ongoing opioid crisis, healthcare providers continue to search for alternatives to opioids that are both safe and effective. While no medicine has an ideal profile, oral ketamine have attributes that may serve emergency department (ED) patients well when dealing with painful conditions. While IV ketamine has been well-studied in the ED setting and oral ketamine has been studied in the post-operative setting, there is limited data describing the safety and effectiveness of oral ketamine in the ED setting. Guided by colleagues from the Anesthesia Acute Pain Service, the Albany Medical Center (AMC) ED has begun giving oral ketamine to appropriate ED patients with painful conditions. We aim to conduct a pilot, un-blinded randomized controlled trial to compare the benefits and detriments of oral ketamine vs. oxycodone in ED patients who require 'second line' pain medicine.
A convenience sample of emergency department patients will be randomized to receive either:
Oxycodone arm:
o The treating provider will order oral oxycodone 5 mg times one
or
o The treating provider has made a deliberate decision that the patient requires (because of weight, prior exposures, etc.) greater than oxycodone 5mg times one
Oral ketamine arm:
o The treating provider will order ketamine 0.75 mg/kg oral times one (max 80mg)
Outcomes measured
Participants will be assessed for
- Pain scores at 30 and 60 minutes after either study drug administration
- Whether they received opioids at 6 hours, 12 hours, and 24 hours after receiving either study drug
- For admitted patients, whether they received opioids upon admission to the hospital, and whether they were discharged with a prescription for opioids
- Whether the participation has received opioid pain medicines, ketamine, or other recreational drugs during the one month after enrolling in the study
- Whether the participation has received opioid pain medicines, ketamine, or other recreational drugs during the three months after enrolling in the study
We will calculate a difference in change in mean pain scores before and after the intervention in each study arm. We will also compare morphine milli-equivalents use during the time intervals above, as well as usage of opioids, ketamine, and recreational drugs during the one month and three month period after enrollment.
Because this is a pilot study, we have not calculated an effect size.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
-
-
New York
-
Albany, New York, Estados Unidos, 12208
- Albany Medical Center Emergency Department
-
Contato:
- Michael Waxman, MD
- Número de telefone: 518-262-3443
- E-mail: waxmanm@amc.edu
-
Contato:
- Andrew Chang, MD, MS
- Número de telefone: 518-262-3443
- E-mail: changa1@amc.edu
-
Investigador principal:
- Michael Waxman, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- ED patient aged 18 years or older AND
- English proficient AND
- Able to give informed consent AND
- Has a painful condition in the ED that includes any of the following: Musculoskeletal extremity pain, Musculoskeletal back or neck pain, Other nociceptive extremity pain
- AND treating provider has deemed the patient necessitating 'second line pain therapy' (meaning: opioids or ketamine)
Exclusion Criteria:
Any of the following:
- Prisoner status
- Pregnant
- Non-English proficient
- Cannot give informed consent
- Requires emergent intravenous pain medicine (as deemed by the treating provider)
- Prior participation in the study
- Previous diagnosis of opioid use disorder
- Previous ketamine addiction
- Patient is in hospice or other palliative care measures
- Contraindication to ketamine, including: Cystitis or bladder pain, Intracranial hypertension, Known coronary artery disease, Age greater than 75 years old, History of prior adverse reaction to ketamine or oxycodone, History or current major psychiatric disorder (as deemed by the treating ED clinician) or history of psychosis
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: oral ketamine
The oral ketamine arm will receive a dose of oral ketamine as a second line pain medication.
|
A dose of oral ketamine administered as a second line pain management medicine in the emergency department.
|
|
Comparador Ativo: oxycodone
The oxycodone arm will receive a dose of oxycodone as a second line pain medication.
|
A dose of oxycodone administered as a second line pain management medicine in the emergency department.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in mean pain score
Prazo: This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.
|
This reflects the mean difference between the pain scores before and after the intervention.
|
This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Usage of morphine in the following 24 hours.
Prazo: 24 hours
|
Usage of morphine in the following 24 hours.
|
24 hours
|
|
Usage of opioids, ketamine, or recreational drugs one month and three months after study enrollment.
Prazo: 1 month and 3 months after study enrollment.
|
Usage of opioids, ketamine, or recreational drugs one month and three months after study enrollment.
|
1 month and 3 months after study enrollment.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Manifestações Neurocomportamentais
- Distúrbios Perceptivos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Agnosia
- Produtos químicos orgânicos
- Compostos heterocíclicos
- Compostos heterocíclicos, anel fundido
- Hidrocarbonetos
- Ciclohexanos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Alcalóides
- Hidrocarbonetos aromáticos policíclicos
- Compostos policíclicos
- Compostos heterocíclicos, 4 ou mais anéis
- Morfinans
- Alcalóides de opiáceos
- Compostos heterocíclicos, anel em ponte
- Fenanthrenes
- Derivados de morfina
- Codeína
- Cetamina
- Oxicodona
Outros números de identificação do estudo
- 7471
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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