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Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

6 mars 2020 mis à jour par: Albert Einstein Healthcare Network

"Does a 1 Plus 1 Hydromorphone Pain Protocol Have a Similar Rate of Respiratory Depression to Physician Discretion Protocol in a Geriatric Population With Moderate to Severe Pain?"

This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of moderate to sever pain in the Emergency Department. Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be enrolled in one of two study arms, "1+1" versus usual care group. 1+1 patients will receive 1mg hydromorphone followed by another 1mg after 15 minutes if pain persists. Usual care group patients will have pain treated per the discretion of the attending physician. Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of long bone fractures in the Emergency Department. Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be screened and randomized to one of two study arms, "1+1" versus usual care group. Neither the research associate, nurse, or attending physician will be blinded to the patients randomization. Patient pain score will be assessed at baseline using VAS score. "1+1" patients will receive 1mg hydromorphone at "timepoint 0" (baseline) followed by another 1mg after 15 minutes (along with repeat VAS pain score) if the patient answers "yes" to "Do you need more pain medicine?" At 60 minutes, patient pain will be assessed a final time and if patient needs more pain medicine, additional treatment will be dictated by physician discretion. Usual care group patients will also have VAS pain scores assessed at timepoint 0, 15 and 60 minutes and will have pain treated per the discretion of the attending physician. Patients will be placed on capnometer for continuous monitoring of respiratory status to guard against any opioid induced respiratory depression. Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression. We propose that the "1+1" hydromorphone protocol is easy to implement, as it includes a set timeline, a standard question, and a set dosage of a potent analgesic. We hypothesize that it will provide adequate analgesia in the majority of patients without causing the anticipated level of respiratory depression.

Type d'étude

Interventionnel

Inscription (Réel)

116

Phase

  • N'est pas applicable

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

  • États-Unis
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19141
        • Albert Einstein Medical Center

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

60 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Any patient who presents a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia
  2. Able to provide consent.

Exclusion Criteria:

  1. Patient or family member unable to consent
  2. Altered mental status
  3. SpO2 less than 95 percent
  4. Allergy to opiates
  5. Hypotension (Systolic blood pressure less than 90 mmHg)
  6. Chronic oxygen dependency or known CO2 retention
  7. Acute ETOH or drug intoxication
  8. History of chronic pain syndrome or chronic use of opiate narcotics
  9. History of opiate/heroin addiction, past or current.
  10. End stage renal disease/dialysis patient
  11. Chronic metabolic acidosis
  12. Physician feels that patient would be poor candidate for study
  13. Weight less than 100 pounds, all patients will be weighted
  14. Patients younger than 60 years of age

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: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 1mg + 1mg Hydromorphone
Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication. If yes, patients will immediately receive 1mg hydromorphone. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.
Médicament: Hydromorphone
1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.
Autres noms:
  • Dilaudide
Comparateur actif: Usual Care Group
Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication. If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per "usual care." Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.
Médicament: Usual care group
Patient will have pain treated at timepoint 0 as per usual care based on physician discretion. At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion.
Autres noms:
  • Dilaudide
  • Morphine
  • Other IV opioid medications

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Respiratory Depression
Délai: From administration of drug (time 0 minutes) to end of study (60 minute mark)
Incidence of respiratory depression (defined as a ETCO2 of 50 mmHg or greater, a 10% change from baseline, or loss of waveform for 15 seconds or greater)
From administration of drug (time 0 minutes) to end of study (60 minute mark)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Successful Treatment of Patient Pain
Délai: 15 min and 60 min after baseline
Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes
15 min and 60 min after baseline
Change in VAS Score
Délai: 15 min and 60 min after baseline
A 13 mm change or greater on a VAS score
15 min and 60 min after baseline
Hypoxia
Délai: From administration of drug (time 0 minutes) to end of study (60 minute mark)
Defined as SpO2 of 93% or less for 15 seconds
From administration of drug (time 0 minutes) to end of study (60 minute mark)
Hypotension
Délai: Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)
Hypotension defined as systolic blood pressure less than 90 mmHg
Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)
Allergic Reaction to Study Drug
Délai: From administration of drug (time 0 minutes) to end of study (60 minute mark)
From administration of drug (time 0 minutes) to end of study (60 minute mark)
Serious Adverse Events
Délai: From administration of drug (time 0 minutes) to end of study (60 minute mark)
Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.
From administration of drug (time 0 minutes) to end of study (60 minute mark)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Albert Einstein Healthcare Network

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 (Réel)

1 décembre 2011

Achèvement primaire (Réel)

16 avril 2014

Achèvement de l'étude (Réel)

16 avril 2014

Dates d'inscription aux études

Première soumission

25 juin 2012

Première soumission répondant aux critères de contrôle qualité

5 février 2013

Première publication (Estimation)

6 février 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 mars 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mars 2020

Dernière vérification

1 décembre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HN - 4325

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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 .

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