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

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ClinicalTrials.gov Identifier: NCT01740492
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : November 1, 2015
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

Tracking Information
First Submitted Date  ICMJE September 26, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date November 1, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
Change in reported pain score at 15 minutes, 30 minutes, and hourly for 6 hrs or until discharge [ Time Frame: Between patient arrival and patient 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
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. [ Time Frame: 15 minutes, 30 minutes, 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…).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
Official Title  ICMJE Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ketamine 0.15mg/kg
    0.15mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.
    Other Name: Ketamine
  • Drug: Ketamine 0.3mg/kg
    0.3 mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.
    Other Name: Ketamine
  • Other: Placebo
    Placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)
Study Arms  ICMJE
  • Experimental: LDK1: Low dose Ketamine (0.15mg/kg)

    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.

    Intervention: Drug: Ketamine 0.15mg/kg
  • Experimental: LDK2: Low dose Ketamine (0.3mg/kg)

    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.

    Intervention: Drug: Ketamine 0.3mg/kg
  • Placebo Comparator: 0.9% Normal Saline
    This group will receive a placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2012)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740492
Other Study ID Numbers  ICMJE 298021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rhode Island Hospital
Study Sponsor  ICMJE Rhode Island Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesca Beaudoin, MD Rhode Island Hospital
PRS Account Rhode Island Hospital
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP