Association Between Body Size and Response to Hydromorphone in ED
6 de octubre de 2020 actualizado 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.
Descripción general del estudio
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
174
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment
Periodo de tiempo: 30 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 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment
Periodo de tiempo: 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
Periodo de tiempo: 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%
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 30 minutes post-treatment
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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30 minutes post-treatment
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Number of Participants With Vomit
Periodo de tiempo: 30 minutes post-treatment
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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.
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30 minutes post-treatment
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Number of Participants With Skin Itching
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Who Desired for More Analgesics
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Adrienne Birnbaum, MD, Jacobi Medical Center, Albert Einstein College of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2011
Finalización primaria (Actual)
1 de octubre de 2012
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
23 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
28 de agosto de 2012
Publicado por primera vez (Estimar)
30 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
6 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2011-445
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
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