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Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

6. mars 2020 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

116

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19141
        • Albert Einstein Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Legemiddel: Hydromorphone
1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.
Andre navn:
  • Dilaudid
Aktiv komparator: 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.
Legemiddel: 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.
Andre navn:
  • Dilaudid
  • Morfin
  • Other IV opioid medications

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Respiratory Depression
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Successful Treatment of Patient Pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Albert Einstein Healthcare Network

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2011

Primær fullføring (Faktiske)

16. april 2014

Studiet fullført (Faktiske)

16. april 2014

Datoer for studieregistrering

Først innsendt

25. juni 2012

Først innsendt som oppfylte QC-kriteriene

5. februar 2013

Først lagt ut (Anslag)

6. februar 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mars 2020

Sist bekreftet

1. desember 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HN - 4325

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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