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Low-dose Ketamine for Acute Pain in the Emergency Department

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ClinicalTrials.gov Identifier: NCT03017248
Recruitment Status : Unknown
Verified January 2017 by HAJER KRAIEM, Faculty of Medicine, Sousse.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
HAJER KRAIEM, Faculty of Medicine, Sousse

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain Drug: Ketamine Drug: Placebos Drug: Morphine Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Benefit of the Association of Low Doses of Ketamine With Intravenous Morphine in the Treatment of Acute Severe Pain in Emergency Department
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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)
Drug: Placebos
0.9% normal saline
Other Name: Normal Saline Flush, 0.9% Injectable Solution

Drug: Morphine
Morphine
Other Name: Morphine Sulfate

Experimental: 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
Drug: Ketamine
ketamine
Other Name: Ketalar, 50 Mg/mL Injectable Solution

Drug: Morphine
Morphine
Other Name: Morphine Sulfate

Experimental: 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
Drug: Ketamine
ketamine
Other Name: Ketalar, 50 Mg/mL Injectable Solution

Drug: Morphine
Morphine
Other Name: Morphine Sulfate




Primary Outcome Measures :
  1. 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 [ Time Frame: 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



Secondary Outcome Measures :
  1. Total patient-perceived pain relief [ Time Frame: 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

  2. Amount of rescue analgesia received [ Time Frame: Two hours after starting protocol ]
    The amount of rescue analgesia received (in milligrams of morphine equivalents) will be recorded.

  3. Time to rescue analgesia [ Time Frame: 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.

  4. The occurrence of adverse events [ Time Frame: 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.


  5. The total dose of morphine administered [ Time Frame: Two hours after starting protocol ]
    The amount of rescue analgesia will be recorded at each time point and the total dose calculated



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017248


Locations
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Tunisia
Faculty of medicine of Sousse
Sousse, Tunisia, 4002
Sponsors and Collaborators
Faculty of Medicine, Sousse
Investigators
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Principal Investigator: Hajer KRAIEM, MD Faculty of medicine of Sousse
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Responsible Party: HAJER KRAIEM, M.D, Faculty of Medicine, Sousse
ClinicalTrials.gov Identifier: NCT03017248    
Other Study ID Numbers: FMSousse
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by HAJER KRAIEM, Faculty of Medicine, Sousse:
pain
ketamine
morphine
analgesia
emergency
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Morphine
Ketamine
Pharmaceutical Solutions
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action