- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04057989
Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
A Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is a retrospective study to determine if there is a relationship between intravenous infusion of ketamine given for analgesia and the use of additional opioid pain medications and patient reported pain levels before and during ketamine usage. The investigator anticipates that records of up to 700 subjects will be reviewed for eligibility. The time period 24 hours before the initial ketamine therapy is initiated along with 24 & 48 hours after the start of ketamine therapy will be the time periods examined. The average/minimum/maximum pain scores during these time periods will be used. Medication usage will be calculated over the 24 hour time periods.
This protocol is presented as an initial step in exploring the possible relationship between the administration of ketamine as an analgesic agent, the potential reduction in pain medications, and the potential reduction of pain levels. With this the goals/objectives are as follows:
Objectives
- To compare morphine consumption in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
- To compare average/minimum/maximum pain scores in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
- To describe the pain trajectory in battlefield injured patients with acute pain after the initiation of ketamine infusions.
- To measure the absolute and proportional incidence of ketamine associated side effects in battlefield injured patients with acute pain following the initiation of ketamine infusions.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20889
- Walter Reed National Military Medical Center
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Battlefield injured from January 2007 to December 2013
- Prescribed a ketamine infusion for acute pain
- Awake, alert (non intubated/sedated), and able to report pain scores 24 hours prior to the start of infusion and up to 48 hours following infusion
Exclusion Criteria:
- Patients who did not receive an injury in theater and did not receive ketamine while being treated by the APS or WRNMMC/WRAMC hospital staff
- No continuous perineural catheter or epidural placement while on ketamine infusion
- Less than 18 years old
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Battlefield Injury with ketamine treatment
Patients who received ketamine infusions to treat pain from January 2007 to December 2013.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Opioid consumption measured in morphine equivalents
Tidsramme: 24 hours before ketamine infusion
|
Amount of opioids consumed within time frame
|
24 hours before ketamine infusion
|
Opioid consumption measured in morphine equivalents
Tidsramme: 24 hours after ketamine infusion
|
Amount of opioids consumed within time frame
|
24 hours after ketamine infusion
|
Opioid consumption measured in morphine equivalents
Tidsramme: 48 hours after ketamine infusion
|
Amount of opioids consumed within time frame
|
48 hours after ketamine infusion
|
Pain scores
Tidsramme: 24 hours before ketamine infusion
|
Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain
Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10 |
24 hours before ketamine infusion
|
Pain scores
Tidsramme: 24 hours after ketamine infusion
|
Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain
Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10 |
24 hours after ketamine infusion
|
Pain scores
Tidsramme: 48 hours after ketamine infusion
|
Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain
Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10 |
48 hours after ketamine infusion
|
Number of ketamine side effects
Tidsramme: 24 hours before ketamine infusion
|
Recorded side effects after ketamine infusion
|
24 hours before ketamine infusion
|
Number of ketamine side effects
Tidsramme: 24 after ketamine infusion
|
Recorded side effects after ketamine infusion
|
24 after ketamine infusion
|
Number of ketamine side effects
Tidsramme: 48 hours after ketamine infusion
|
Recorded side effects after ketamine infusion
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48 hours after ketamine infusion
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Michael Kent, MD, Walter Reed National Military Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Smerte
- Nevrologiske manifestasjoner
- Sår og skader
- Kraniocerebralt traume
- Traumer, nervesystemet
- Traumer og stressorerelaterte lidelser
- Hjerneskader
- Stresslidelser, traumatiske
- Stresslidelser, posttraumatisk
- Hjerneskader, traumatiske
- Akutt smerte
- Amputasjon, traumatisk
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Anestesimidler, dissosiativ
- Anestesimidler, intravenøst
- Anestesimidler, general
- Bedøvelsesmidler
- Eksitatoriske aminosyreantagonister
- Eksitatoriske aminosyremidler
- Ketamin
Andre studie-ID-numre
- 399623
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