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Low-dose Ketamine for Acute Pain in the Emergency Department

Primary Purpose

Pain

Status
Unknown status
Phase
Phase 1
Locations
Tunisia
Study Type
Interventional
Intervention
Ketamine
Placebos
Morphine
Sponsored by
Faculty of Medicine, Sousse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, ketamine, morphine, analgesia, emergency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine of Sousse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Morphine and Placebo

Morphine and Ketamine 0.15

Morphine and Ketamine 0.3

Arm Description

Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg)

Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg

Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg

Outcomes

Primary Outcome Measures

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
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

Total patient-perceived pain relief
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
Amount of rescue analgesia received
The amount of rescue analgesia received (in milligrams of morphine equivalents) will be recorded.
Time to rescue analgesia
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.
The occurrence of adverse events
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.
The total dose of morphine administered
The amount of rescue analgesia will be recorded at each time point and the total dose calculated

Full Information

First Posted
January 9, 2017
Last Updated
January 29, 2017
Sponsor
Faculty of Medicine, Sousse
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1. Study Identification

Unique Protocol Identification Number
NCT03017248
Brief Title
Low-dose Ketamine for Acute Pain in the Emergency Department
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Medicine, Sousse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, ketamine, morphine, analgesia, emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine and Placebo
Arm Type
Active Comparator
Arm Description
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg)
Arm Title
Morphine and Ketamine 0.15
Arm Type
Experimental
Arm Description
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg
Arm Title
Morphine and Ketamine 0.3
Arm Type
Experimental
Arm Description
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar, 50 Mg/mL Injectable Solution
Intervention Description
ketamine
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Normal Saline Flush, 0.9% Injectable Solution
Intervention Description
0.9% normal saline
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Sulfate
Intervention Description
Morphine
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Two hours after starting protocol
Secondary Outcome Measure Information:
Title
Total patient-perceived pain relief
Description
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
Time Frame
Two hours after starting protocol
Title
Amount of rescue analgesia received
Description
The amount of rescue analgesia received (in milligrams of morphine equivalents) will be recorded.
Time Frame
Two hours after starting protocol
Title
Time to rescue analgesia
Description
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.
Time Frame
Two hours after starting protocol
Title
The occurrence of adverse events
Description
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.
Time Frame
Two hours after starting protocol
Title
The total dose of morphine administered
Description
The amount of rescue analgesia will be recorded at each time point and the total dose calculated
Time Frame
Two hours after starting protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hajer KRAIEM, MD
Organizational Affiliation
Faculty of medicine of Sousse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine of Sousse
City
Sousse
ZIP/Postal Code
4002
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Low-dose Ketamine for Acute Pain in the Emergency Department

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