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Safety and Efficacy Study of Hydromorphone and Morphine

13 agosto 2018 aggiornato da: Andrew Chang, MD, Montefiore Medical Center

Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial

To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

There is widespread agreement that pain is under-treated in the Emergency Department (ED). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved. Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients' acute pain. In spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

198

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • New York
      • Bronx, New York, Stati Uniti, 10467
        • Montefiore Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 21 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • adults between the ages of 21 and 65 who presented to the ED with acute pain (defined as pain less than 7 days in duration) (23) of sufficient severity in the judgment of the ED attending to warrant use of IV opioids.

Exclusion Criteria:

  • previous allergy to morphine or hydromorphone
  • systolic blood pressure less than 90 mmHg
  • alcohol intoxication as judged by the attending physician
  • use of other opioids within the past 7 days
  • use of an Monoamine Oxidase (MAO) inhibitor
  • chronic pain syndromes (such as sickle cell disease or fibromyalgia)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Morphine

single dose of intravenous (IV) morphine, 0.1 mg/kg

intervention: 0.1 mg/kg IV morphine

0.1 mg/kg IV morphine
Sperimentale: Hydromorphone

single dose of intravenous (IV) hydromorphone, 0.015 mg/kg

intervention: 0.015 mg/kg IV hydromorphone

0.015 mg/kg IV hydromorphone
Altri nomi:
  • Dilaudido

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Pain Intensity from baseline to 30 minutes after medications were infused.
Lasso di tempo: baseline to 30 minutes after medication infused
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable)
baseline to 30 minutes after medication infused

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain intensity 5 minutes after medication is given
Lasso di tempo: 5 minutes after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
5 minutes after medication is given
Pain intensity 30 minutes after medication is given
Lasso di tempo: 30 minutes after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
30 minutes after medication is given
Pain intensity 2 hours after medication is given
Lasso di tempo: 2 hours after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
2 hours after medication is given
Number of participants experiencing vomiting between baseline to 5 minutes after medication is given
Lasso di tempo: baseline to 5 minutes after medication is given
Number of participants who experienced vomiting and required medication between baseline and 5 minutes after medication was infused
baseline to 5 minutes after medication is given
Number of participants experiencing vomiting between 6 minutes after medication is given to 30 minutes after medication is given
Lasso di tempo: 6 minutes after medication is given to 30 minutes after medication is given
Number of participants who experienced vomiting and required medication between 6 minutes after medication was infused and 30 minutes after medication was infused
6 minutes after medication is given to 30 minutes after medication is given
Number of participants experiencing vomiting between 31 minutes after medication is given to 120 minutes after medication is given
Lasso di tempo: 31 minutes after medication is given to 120 minutes after medication is given
Number of participants who experienced vomiting and required medication between 31 minutes after medication was infused and 120 minutes after medication was infused
31 minutes after medication is given to 120 minutes after medication is given
Number of participants who received additional pain medication between baseline and 5 minutes after medication was infused
Lasso di tempo: baseline to 5 minutes after medication was infused
Number of participants for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between baseline and 5 minutes after medication was infused
baseline to 5 minutes after medication was infused
Number of participants who received additional pain medication between 6 and 30 minutes after medication was infused
Lasso di tempo: 6 minutes to 30 minutes after medication was infused
Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 6 and 30 minutes after the medication was infused
6 minutes to 30 minutes after medication was infused
Number of participants who received additional pain medication between 31 and 120 minutes after medication was infused
Lasso di tempo: 31 minutes to 120 minutes after medication was infused
Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 31 and 120 minutes after medication was infused
31 minutes to 120 minutes after medication was infused

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Andrew K Chang, MD, Montefiore Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2004

Completamento primario (Effettivo)

1 gennaio 2005

Completamento dello studio (Effettivo)

1 gennaio 2005

Date di iscrizione allo studio

Primo inviato

12 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

12 settembre 2005

Primo Inserito (Stima)

20 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 agosto 2018

Ultimo verificato

1 agosto 2018

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dolore

Prove cliniche su Morphine

3
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