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- Klinische proef NCT00195910
Safety and Efficacy Study of Hydromorphone and Morphine
13 augustus 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
198
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
New York
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Bronx, New York, Verenigde Staten, 10467
- Montefiore Medical Center
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
21 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Morphine
single dose of intravenous (IV) morphine, 0.1 mg/kg intervention: 0.1 mg/kg IV morphine |
0.1 mg/kg IV morphine
|
Experimenteel: Hydromorphone
single dose of intravenous (IV) hydromorphone, 0.015 mg/kg intervention: 0.015 mg/kg IV hydromorphone |
0.015 mg/kg IV hydromorphone
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Pain Intensity from baseline to 30 minutes after medications were infused.
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Pain intensity 5 minutes after medication is given
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Andrew K Chang, MD, Montefiore Medical Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2004
Primaire voltooiing (Werkelijk)
1 januari 2005
Studie voltooiing (Werkelijk)
1 januari 2005
Studieregistratiedata
Eerst ingediend
12 september 2005
Eerst ingediend dat voldeed aan de QC-criteria
12 september 2005
Eerst geplaatst (Schatting)
20 september 2005
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 augustus 2018
Laatste update ingediend die voldeed aan QC-criteria
13 augustus 2018
Laatst geverifieerd
1 augustus 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MMC-04-08-225
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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