- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03017248
Low-dose Ketamine for Acute Pain in the Emergency Department
Benefit of the Association of Low Doses of Ketamine With Intravenous Morphine in the Treatment of Acute Severe Pain in Emergency Department
This study aims to determine the efficacy and safety of low dose ketamine in association with IV morphine in the management of acute moderate to severe pain in emergency department.
The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Management of pain in the Emergency Department is challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, the use of opioids alone for pain control is often associated with inadequate analgesia and increased adverse events.
Low-dose ketamine has been shown to improve pain perception and produce an opioid-sparing effect when given perioperatively.
Its use in the ED may probably play a role in maximizing analgesia.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
-
Sousse, Tunisia, 4002
- Faculty of medicine of Sousse
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Able to understand and give informed consent
- Comfortable with the experimental protocol as outlined to them by the research team
- Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
- Acute pain, pain duration < 7days
- Deemed by treating ED attending physician to require IV opioid analgesia
Exclusion Criteria:
- Neurologic, respiratory, or hemodynamic compromise
- Pregnancy or breastfeeding
- Known or suspected allergy to ketamine or morphine
- Known Renal (Cr>2.0) or Liver Failure
- Unstable psychiatric disease (as per treating physician)
- History of stroke
- History of cardiac disease or coronary artery disease
- History of chronic respiratory disease
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Morphine and Placebo
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg)
|
Morfina
Altri nomi:
0.9% normal saline
Altri nomi:
|
Sperimentale: Morphine and Ketamine 0.15
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg
|
Morfina
Altri nomi:
ketamina
Altri nomi:
|
Sperimentale: Morphine and Ketamine 0.3
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg
|
Morfina
Altri nomi:
ketamina
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Efficacy of analgesia: To assess the primary outcome of pain relief, we used patient-reported pain scores. We consider the pain decreasing of at least 50% of pain score and the summed pain-intensity difference (SPID) over 2 hours
Lasso di tempo: Two hours after starting protocol
|
At baseline, to assess our primary aim, efficacy of pain control, we will use patient reported pain scores and amount of rescue analgesia (parenteral morphine) received. Trained residents will ask participants to report their pains scores using a numerical pain rating scale (NPRS). The NPRS used will be a 0 to 10 rating scale. Baseline NPRS will be measured after randomization, but just before administration of morphine. Change in reported pain score during the protocol will be analysed. The SPID was calculated using the pain-intensity difference (PID) at each of these study time points. The PID for a given time point is equal to the baseline NPRS minus the subsequent NPRS at each study time point. SPID is the summation of the PID at each of the study time points, weighted using the amount of time since the prior assessment |
Two hours after starting protocol
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Total patient-perceived pain relief
Lasso di tempo: Two hours after starting protocol
|
The total patient-perceived pain relief will be calculated using weighted sum of the pain relief scale performed at each study time point.
This pain relief scale is a five-point scale that asks participants to rate pain relief as complete = 4, a lot = 3, some = 2, a little = 1, and none = 0
|
Two hours after starting protocol
|
Amount of rescue analgesia received
Lasso di tempo: Two hours after starting protocol
|
The amount of rescue analgesia received (in milligrams of morphine equivalents) will be recorded.
|
Two hours after starting protocol
|
Time to rescue analgesia
Lasso di tempo: Two hours after starting protocol
|
Time to rescue analgesia will be calculated as the time from administration of the last study medication (placebo or ketamine) to administration of an opioid analgesic.
|
Two hours after starting protocol
|
The occurrence of adverse events
Lasso di tempo: Two hours after starting protocol
|
We will record participant-reported dizziness, nausea, vomiting, confusion, dysphoria, visual disturbances, or other complaints at baseline and each study time point. All patients will be monitored for the duration of the study period and vital signs will be recorded at each time point. The presence of tachycardia (heart rate > 100 beats/min.), hypotension (systolic blood pressure [sBP] < 100 mm Hg), hypertension (sBP > 180 mm Hg or diastolic blood pressure [dBP] > 100 mm Hg), and respiratory depression (respiratory rate < 12 breaths/min, oxygen saturation < 92%, or need for supplemental oxygen) will be noted. |
Two hours after starting protocol
|
The total dose of morphine administered
Lasso di tempo: Two hours after starting protocol
|
The amount of rescue analgesia will be recorded at each time point and the total dose calculated
|
Two hours after starting protocol
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Hajer KRAIEM, MD, Faculty of medicine of Sousse
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Attributi della malattia
- Emergenze
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Anestetico, Dissociativo
- Anestetici, per via endovenosa
- Anestetici, Generale
- Anestetici
- Antagonisti degli aminoacidi eccitatori
- Agenti di aminoacidi eccitatori
- Analgesici, oppioidi
- Narcotici
- Ketamina
- Soluzioni farmaceutiche
- Morfina
Altri numeri di identificazione dello studio
- FMSousse
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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
-
University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team
Prove cliniche su Morfina
-
University of LuebeckCompletatoInfarto miocardico acutoGermania