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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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Sousse, Tunisien, 4002
- Faculty of Medicine of Sousse
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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)
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Morfin
Andra namn:
0.9% normal saline
Andra namn:
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Experimentell: 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
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Morfin
Andra namn:
ketamin
Andra namn:
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Experimentell: 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
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Morfin
Andra namn:
ketamin
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: Two hours after starting protocol
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Total patient-perceived pain relief
Tidsram: Two hours after starting protocol
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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
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Two hours after starting protocol
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Amount of rescue analgesia received
Tidsram: Two hours after starting protocol
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The amount of rescue analgesia received (in milligrams of morphine equivalents) will be recorded.
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Two hours after starting protocol
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Time to rescue analgesia
Tidsram: Two hours after starting protocol
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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.
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Two hours after starting protocol
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The occurrence of adverse events
Tidsram: Two hours after starting protocol
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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
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The total dose of morphine administered
Tidsram: Two hours after starting protocol
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The amount of rescue analgesia will be recorded at each time point and the total dose calculated
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Two hours after starting protocol
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Hajer KRAIEM, MD, Faculty of Medicine of Sousse
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Sjukdomsegenskaper
- Nödsituationer
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Bedövningsmedel, dissociativa
- Bedövningsmedel, intravenöst
- Anestesimedel, general
- Bedövningsmedel
- Excitatoriska aminosyraantagonister
- Excitatoriska aminosyror
- Analgetika, Opioid
- Narkotika
- Ketamin
- Farmaceutiska lösningar
- Morfin
Andra studie-ID-nummer
- FMSousse
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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