Association Between Body Size and Response to Hydromorphone in ED
6 de outubro de 2020 atualizado por: Albert Einstein College of Medicine
Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain
Pain is the most common complaint for patients presenting to the emergency department (ED).
Inadequate pain relief is also a common problem in ED.
Patients' pain perceptions and responses to intravenous opioids vary widely and are influenced by multiple factors.
The objective of the current study is to examine the association between total body weight, BMI (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.
Visão geral do estudo
Descrição detalhada
Pain is the most common complaint for patients presenting to the emergency department (ED). Morphine and hydromorphone are the two most commonly administrated intravenous opioid analgesics. However, a large inter-individual variation in the response to morphine or hydromorphone has been observed and a significant number of patients do not have satisfactory pain relief after receiving commonly administered doses of these two medications. Current studies have focused on investigating optimal strategies of intravenous opioid use for moderate and severe pain in the ED.
Contrary to the commonly recommended total body weight (TBW) based dosing strategy, a recent publication did not demonstrate a linear relationship between TBW and clinical response to morphine.
The ultimate goal of the research is to identify optimal methods of dosing opioids to alleviate pain in ED patients. The objective of this study is to examine the association between two measures of body size/body composition and response to a standard dose of hydromorphone. The null hypothesis is that there is no association between the measures of body size/composition and response to 1 mg hydromorphone, and thus no difference between the associations. If a strong association exists between TBW or BMI and pain response, it will lend support for the importance of taking body size or composition into account when making decisions about hydromorphone dosing in the ED. It will lay the groundwork for future studies of analgesic dosing. This is of particular importance given the increasing prevalence of obesity in the US and other developed nations.
Specific Aims:
- To test the association between analgesic response to a standard dose of hydromorphone and total body weight in ED patients with acute pain requiring intravenous opioid analgesia.
- To test the association between analgesic response to a standard dose of hydromorphone and BMI.
- To compare the associations between analgesic response to a standard dose of hydromorphone and the two measures of body size/composition, BMI and TBW.
- To assess whether the associations between response to hydromorphone and these measures of body size/composition are confounded or modified by gender, age, ethnicity and certain genetic polymorphisms.
The results of the current study will suggest whether body size or composition play a role in the clinical response to hydromorphone and may lay the groundwork for further studies to determine whether dosing should be modified to take these characteristics into account either continuously, e.g. 0.015 mg/kg hydromorphone or categorically (increasing doses by category of BMI).
Tipo de estudo
Intervencional
Inscrição (Real)
174
Estágio
- Fase 2
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
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New York
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Bronx, New York, Estados Unidos, 10461
- Jacobi Medical Center
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Bronx, New York, Estados Unidos, 10467
- North Central Bronx Hospital
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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 a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- English or Spanish speaking
- Age 18 - 65 years old
- Acute pain (less than 7 days in duration)
- Pain with sufficient severity to warrant use of intravenous opioids in the judgment of ED attending physician
Exclusion Criteria:
- Allergy to hydromorphone
- Systolic blood pressure < 90 mm Hg
- Room air oxygen saturation by pulse oximetry < 95% at baseline without supplemental oxygen
- Alcohol or other drug intoxication as judged by the attending physician
- Suspicion of drug seeking by ED physician
- Use of opioids within the past 24 hours
- Use of a monoamine oxidase inhibitor
- Concurrent use of benzodiazepines
- Presence of a chronic pain syndrome (such as sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia)
- History of COPD, sleep apnea, renal failure, liver disease
- Pregnancy or breast feeding
- Prior entry of patient in the study
- Inability or unwillingness to provide informed consent
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
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Hydromorphone
Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Pain scale change, patients' satisfaction, requirements for additional pain medications, side effects and adverse events will be recorded at 15 and 30 minutes.
Patients' weight and height will be measured.
Age, gender, and race/ethnicity will also be recorded.
Blood draw for genetic study will be performed.
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a fixed dose (1 mg) of hydromorphone will be given to the study subjects
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment
Prazo: 30 minutes post-treatment
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Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW).
The reported value represents the correlation coefficient.
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30 minutes post-treatment
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Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment
Prazo: 30 minutes post-treatment
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Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI).
The reported value represents the correlation coefficient.
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30 minutes post-treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment
Prazo: 15 minutes post-treatment
|
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW).
The reported value represents the correlation coefficient.
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15 minutes post-treatment
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Pain Treatment Satisfaction Levels as Assessed by Self-report
Prazo: 30 minutes post-treatment
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Participant's satisfaction with their treatment were assessed by self-report.
After treatment, participants were asked "How satisfied are you with the result of your pain treatment today?" and they were told to pick their satisfaction level from "very dissatisfied," "dissatisfied," "uncertain," "satisfied," and "very satisfied."
Participants at each level is reported.
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30 minutes post-treatment
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Number of Participants With Oxygen Saturation Level < 92%
Prazo: 30 minutes post-treatment
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Opioids can induce respiratory depression, which could lead to low oxygen saturation level.
Prolonged low oxygen saturation level < 92% could cause brain damage.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
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30 minutes post-treatment
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Number of Participants With Nausea
Prazo: 30 minutes post-treatment
|
Opioids can could induce nausea.
Number of participants with nausea is reported.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
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30 minutes post-treatment
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Effect of Gender on the Correlation Between TBW and Change in Pain Intensity
Prazo: 30 minutes post-treatment
|
This study evaluated the effect of gender on the correlation between Total Body Weight (TBW) and change in pain intensity.
Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW).
The reported value represents the correlation coefficient.
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30 minutes post-treatment
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Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity
Prazo: 30 minutes post-treatment
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This study evaluated the effect of race/ethnicity on the correlation between total body weight (TBW) and change in pain intensity.
Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW).
The reported value represents the correlation coefficient.
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30 minutes post-treatment
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Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity
Prazo: 30 minutes post-treatment
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This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity.
Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid receptor (OPRM1, A118G).
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
The median and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.
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30 minutes post-treatment
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Effects of Age on the Correlation Between TBW and Change in Pain Intensity
Prazo: 30 minutes post-treatment
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Age might affect the responses to the hydromorphone treatment.
The effects of age on the correlation between total body weight (TBW) and change in pain intensity.
The mean of age was compared in TBW tertile groups.
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30 minutes post-treatment
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Number of Participant With Systolic Blood Pressure < 90 mmHg
Prazo: 30 minutes post-treatment
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Opioids can induce low blood pressure.
Prolonged low systolic blood pressure < 90 mmHg can cause shock and multi-organ failure.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
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30 minutes post-treatment
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Effect of Gender on the Correlation Between BMI and Change in Pain Intensity
Prazo: 30 minutes post-treatment
|
This study evaluated the effect of gender on the correlation between body mass index (BMI) and change in pain intensity.
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI).
The reported value represents the correlation coefficient.
|
30 minutes post-treatment
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Number of Participants With Vomit
Prazo: 30 minutes post-treatment
|
Opioids can induce vomit.
Number of participants with vomit is reported.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
|
30 minutes post-treatment
|
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Number of Participants With Skin Itching
Prazo: 30 minutes post-treatment
|
Opioids can induce skin itching.
Number of participants with skin itching is reported.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
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30 minutes post-treatment
|
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Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment
Prazo: 15 minutes post-treatment
|
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI).
The reported value represents the correlation coefficient.
|
15 minutes post-treatment
|
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Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity
Prazo: 30 minutes post-treatment
|
This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity.
Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid transporter (ABCB1, C3435T).
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.
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30 minutes post-treatment
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Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity
Prazo: 30 minutes post-treatment
|
This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity.
Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving pain sensitivity (COMT, G1947A).
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.
|
30 minutes post-treatment
|
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Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity
Prazo: 30 minutes post-treatment
|
This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity.
Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid metabolism (UGT2B7, -G840A).
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.
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30 minutes post-treatment
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants Who Desired for More Analgesics
Prazo: 30 minutes post-treatment
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Some participants liked to receive additional analgesics after hydromorphone treatment.
Number of participants who desired for additional analgesics is reported.
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30 minutes post-treatment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Adrienne Birnbaum, MD, Jacobi Medical Center, Albert Einstein College of Medicine
Publicações e links úteis
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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 outubro de 2011
Conclusão Primária (Real)
1 de outubro de 2012
Conclusão do estudo (Real)
1 de dezembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
23 de agosto de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de agosto de 2012
Primeira postagem (Estimativa)
30 de agosto de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de outubro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2011-445
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
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