Association Between Body Size and Response to Hydromorphone in ED
6 octobre 2020 mis à jour par: 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.
Aperçu de l'étude
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Réel)
174
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
New York
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Bronx, New York, États-Unis, 10461
- Jacobi Medical Center
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Bronx, New York, États-Unis, 10467
- North Central Bronx Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment
Délai: 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
Délai: 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 body mass index (BMI).
The reported value represents the correlation coefficient.
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30 minutes post-treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment
Délai: 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.
|
15 minutes post-treatment
|
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Pain Treatment Satisfaction Levels as Assessed by Self-report
Délai: 30 minutes post-treatment
|
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%
Délai: 30 minutes post-treatment
|
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
Délai: 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.
|
30 minutes post-treatment
|
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Effect of Gender on the Correlation Between TBW and Change in Pain Intensity
Délai: 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.
|
30 minutes post-treatment
|
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Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity
Délai: 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.
|
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
Délai: 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 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
Délai: 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
Délai: 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.
|
30 minutes post-treatment
|
|
Effect of Gender on the Correlation Between BMI and Change in Pain Intensity
Délai: 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
Délai: 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
Délai: 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.
|
30 minutes post-treatment
|
|
Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment
Délai: 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
Délai: 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.
|
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
Délai: 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
|
|
Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants Who Desired for More Analgesics
Délai: 30 minutes post-treatment
|
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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Adrienne Birnbaum, MD, Jacobi Medical Center, Albert Einstein College of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2011
Achèvement primaire (Réel)
1 octobre 2012
Achèvement de l'étude (Réel)
1 décembre 2012
Dates d'inscription aux études
Première soumission
23 août 2012
Première soumission répondant aux critères de contrôle qualité
28 août 2012
Première publication (Estimation)
30 août 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 octobre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2011-445
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .