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Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department

Primary Purpose

Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine 0.15mg/kg
Ketamine 0.3mg/kg
Placebo
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Ketamine, Acute pain, Pain control, Pain

Eligibility Criteria

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

Inclusion Criteria:

  • English speaking
  • Adults age 18-65
  • 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
  • ASA (American Society of Anesthesiologists) class I or II

Exclusion Criteria:

  • Previously enrolled in the study
  • Neurologic, respiratory, or hemodynamic compromise
  • GCS (Glasgow Coma Scale) <15
  • Pox <94%, RR <10, or RR >22
  • SBP <90, SBP>180, or DBP >110
  • Discretion of treating physician
  • Pregnancy or breastfeeding
  • Known or suspected allergy to ketamine or morphine
  • Ketamine within 24 hours of presentation (prescription or illicit drugs)
  • Conscious sedation in ED (per treating physician), includes ketamine (for non-study purposes)
  • Known Renal (Cr>2.0) or Liver Failure
  • Unstable psychiatric disease (as per treating physician)
  • History of stroke
  • History of cardiac disease
  • Prior myocardial infarction; Angina (Stable or Unstable)
  • Cardiac stents or bypass surgery

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LDK1: Low dose Ketamine (0.15mg/kg)

LDK2: Low dose Ketamine (0.3mg/kg)

0.9% Normal Saline

Arm Description

Participants randomized to the first group, LDK1, will receive an intravenous injection of low dose ketamine (0.15mg/kg). All participants, regardless of the group, will receive a dose of morphine(0.15mg/kg) at the same time the study drug is administered.

Participants randomized to the second group, LDK2, will receive an intravenous injection of low dose ketamine (0.3mg/kg). All participants, regardless of the group, will receive a dose of morphine(0.15mg/kg) at the same time the study drug is administered.

This group will receive a placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)

Outcomes

Primary Outcome Measures

Change in reported pain score at 15 minutes, 30 minutes, and hourly for 6 hrs or until discharge
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 research assistants (RA) 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: a rating of 0 corresponds to "no pain at all," whereas a rating of 10 is the "worst pain imaginable." Baseline NPRS will be measured after randomization, but just before administration of ketamine or placebo injection and morphine (Baseline). Repeat measurements will be taken at 15 minutes, 30 minutes, and hourly following treatment with the study drug, for 6hrs or until the patient leaves the ED. The amount of rescue analgesia will be recorded at each time point. The ED course will also be reviewed post hoc by the RAs and physician investigators to confirm analgesia received. The main outcome measure will be the change in pain score over time.

Secondary Outcome Measures

Safety--Determine the incidence of adverse events associated with ketamine and morphine, versus morphine alone at 5 minutes, 30 minutes, and hourly up to 6 hours.
Adverse events will further be defined as Hypotension (SBP < 90), Hypertension (SBP >180, or Diastolic Blood Pressure >110), Presence of nausea/vomiting, presence of hallucinations, Respiratory depression (pOx<92%, Respirator Rate<12, EtCO2 >40), and need for naloxone. All patients will be monitored continuously with cardiac telemetry, pulse oximetry, and capnography following administration of the study drug. Level of sedation will be assessed using an adaptation of the Ramsay Scoring System and the Pasero Opioid Induced Sedation Scale. (Appendix 2) Further, the ED and inpatient course will be reviewed post hoc by the RAs and physician investigators who will record: Time to inpatient admission or discharge, inpatient length of stay, time to operative intervention, outcome of admission (i.e. discharge to home, SNF, rehab) and any morbidity and mortality suffered by the patient and medical complications (myocardial infarction, respiratory infection, etc…).

Full Information

First Posted
September 26, 2012
Last Updated
September 6, 2022
Sponsor
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01740492
Brief Title
Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
Official Title
Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to address both the management and evaluation of pain. The primary aim of this study is to determine the efficacy of low dose ketamine in adults with moderate to severe pain in the emergency department as compared with parenteral opioids alone. Another aim is to examine the safety of low dose ketamine compared to opioids alone. 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 and assessment of pain in the Emergency Department (ED) can be challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, inadequate analgesia is often a problem when opioids alone are relied on for pain control. In the peri-operative setting ketamine has been used as an adjunct to opioids for acute pain. Ketamine may play a role in maximizing analgesia in the ED.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Ketamine, Acute pain, Pain control, Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LDK1: Low dose Ketamine (0.15mg/kg)
Arm Type
Experimental
Arm Description
Participants randomized to the first group, LDK1, will receive an intravenous injection of low dose ketamine (0.15mg/kg). All participants, regardless of the group, will receive a dose of morphine(0.15mg/kg) at the same time the study drug is administered.
Arm Title
LDK2: Low dose Ketamine (0.3mg/kg)
Arm Type
Experimental
Arm Description
Participants randomized to the second group, LDK2, will receive an intravenous injection of low dose ketamine (0.3mg/kg). All participants, regardless of the group, will receive a dose of morphine(0.15mg/kg) at the same time the study drug is administered.
Arm Title
0.9% Normal Saline
Arm Type
Placebo Comparator
Arm Description
This group will receive a placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.15mg/kg
Other Intervention Name(s)
Ketamine
Intervention Description
0.15mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.3mg/kg
Other Intervention Name(s)
Ketamine
Intervention Description
0.3 mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)
Primary Outcome Measure Information:
Title
Change in reported pain score at 15 minutes, 30 minutes, and hourly for 6 hrs or until discharge
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 research assistants (RA) 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: a rating of 0 corresponds to "no pain at all," whereas a rating of 10 is the "worst pain imaginable." Baseline NPRS will be measured after randomization, but just before administration of ketamine or placebo injection and morphine (Baseline). Repeat measurements will be taken at 15 minutes, 30 minutes, and hourly following treatment with the study drug, for 6hrs or until the patient leaves the ED. The amount of rescue analgesia will be recorded at each time point. The ED course will also be reviewed post hoc by the RAs and physician investigators to confirm analgesia received. The main outcome measure will be the change in pain score over time.
Time Frame
Between patient arrival and patient discharge
Secondary Outcome Measure Information:
Title
Safety--Determine the incidence of adverse events associated with ketamine and morphine, versus morphine alone at 5 minutes, 30 minutes, and hourly up to 6 hours.
Description
Adverse events will further be defined as Hypotension (SBP < 90), Hypertension (SBP >180, or Diastolic Blood Pressure >110), Presence of nausea/vomiting, presence of hallucinations, Respiratory depression (pOx<92%, Respirator Rate<12, EtCO2 >40), and need for naloxone. All patients will be monitored continuously with cardiac telemetry, pulse oximetry, and capnography following administration of the study drug. Level of sedation will be assessed using an adaptation of the Ramsay Scoring System and the Pasero Opioid Induced Sedation Scale. (Appendix 2) Further, the ED and inpatient course will be reviewed post hoc by the RAs and physician investigators who will record: Time to inpatient admission or discharge, inpatient length of stay, time to operative intervention, outcome of admission (i.e. discharge to home, SNF, rehab) and any morbidity and mortality suffered by the patient and medical complications (myocardial infarction, respiratory infection, etc…).
Time Frame
15 minutes, 30 minutes, hourly up to 6 hours

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: English speaking Adults age 18-65 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 ASA (American Society of Anesthesiologists) class I or II Exclusion Criteria: Previously enrolled in the study Neurologic, respiratory, or hemodynamic compromise GCS (Glasgow Coma Scale) <15 Pox <94%, RR <10, or RR >22 SBP <90, SBP>180, or DBP >110 Discretion of treating physician Pregnancy or breastfeeding Known or suspected allergy to ketamine or morphine Ketamine within 24 hours of presentation (prescription or illicit drugs) Conscious sedation in ED (per treating physician), includes ketamine (for non-study purposes) Known Renal (Cr>2.0) or Liver Failure Unstable psychiatric disease (as per treating physician) History of stroke History of cardiac disease Prior myocardial infarction; Angina (Stable or Unstable) Cardiac stents or bypass surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Beaudoin, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department

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