- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02621619
IV Acetaminophen as an Analgesic Adjunct
Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Bronx, New York, Forente stater, 10467
- Montefiore Medical Center Moses Division Emergency Department
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician
Exclusion Criteria:
- Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
- Prior adverse reaction to hydromorphone, morphine, or acetaminophen.
- Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
- Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
- Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
- Heart Rate (HR) < 60/min: Opioids can cause bradycardia.
- Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
- Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
- Patients using transdermal pain patches
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: IV acetaminophen + 0.5 mg IV hydromorphone
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
|
1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
Andre navn:
|
|
Placebo komparator: Normal saline + 0.5 mg IV hydromorphone
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
|
100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
Tidsramme: baseline and 60 minutes after medication was infused
|
Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given. |
baseline and 60 minutes after medication was infused
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity Over Time
Tidsramme: baseline to 5 min, 15 min, 30 min, and 45 minutes
|
Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)]. Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes |
baseline to 5 min, 15 min, 30 min, and 45 minutes
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Andrew Chang, MD, MS, Albany Medical College
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2015-5369
- 7K23AG033100-07 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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